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PubMed2005

Pharmacokinetics of ketorolac pentyl ester, a novel ester derivative of ketorolac, in rabbits.

Ketorolac is a potent nonsteroidal anti-inflammatory drug. Recently, a novel ester of ketorolac, ketorolac pentyl ester, was synthesized. When prepared in injectable oil, the new agent demonstrated a long duration of action. Ketorolac pentyl ester was synthesized using a prodrug design by esterification of ketorolac, and appeared to be a prodrug of ketorolac in vivo, which needed to be confirmed. The aim of the present study was to establish the prodrug's pharmacokinetics in vivo, and to confirm whether or not ketorolac pentyl ester was a prodrug of ketorolac. Pharmacokinetic profiles of intravenous ketorolac and its pentyl ester on an equal-molar basis in six rabbits were evaluated. A high-performance liquid chromatographic method was used to determine the plasma concentrations of ketorolac and its pentyl ester. We found that the plasma concentrations of ketorolac pentyl ester declined rapidly after injection and so did the conversion of ketorolac pentyl ester to ketorolac. Also, the conversion of ketorolac was proved complete when compared with intravenous ketorolac under an equi-molar basis. In conclusion, this in vivo pharmacokinetic study confirmed that keterolac pentyl ester was a prodrug of keterolac.

Animals↗
PubMed2006

Evaluation of 0.4% ketorolac tromethamine ophthalmic solution versus 0.5% ketorolac tromethamine ophthalmic solution after phacoemulsification and intraocular lens implantation.

PURPOSE: The aim of this study was to compare the effectiveness and patient tolerance of 0.4% ketorolac tromethamine ophthalmic solution and 0.5% ketorolac tromethamine ophthalmic solution after routine phacoemulsification and lens implantation. SETTING: The setting for this study was the Storm Eye Institute and Magill Research Center for Vision Correction, Medical University of South Carolina (Charleston, SC). METHODS: This work was a prospective, double-masked study that included 40 eyes of 40 patients randomly assigned to receive topical treatment with 0.4% ketorolac or 0.5% ketorolac, starting 15 min prior to routine phacoemulsification and foldable posterior chamber intraocular lens implantation. Following the procedure, patients were instructed to use the assigned treatment agent 4 times a day after surgery for 1 week and twice a day for 3 weeks, when drops were discontinued. Slit-lamp examination, intraocular pressure (IOP), laser cell and flare measurements, and subjective patient tolerance were evaluated postoperatively at 1, 7, and 30 d. Comparisons between the 2 groups were made at each visit, as well as comparisons to baseline. A P=value less than .05 was considered statistically significant. RESULTS: At day 1, a higher percentage of patients (70% vs. 40%) reported symptoms (mainly foreign body sensation and stinging/burning) in the 0.5% ketorolac group, compared to the 0.4% ketorolac group. No significant differences were found between the 2 groups over time regarding best-corrected visual acuity (BCVA), IOP, slit-lamp assessment of cells, and cell and flare measured using the laser cell/flare meter. CONCLUSIONS: Treatment with 0.4% ketorolac tromethamine ophthalmic solution is as effective as 0.5% ketorolac tromethamine ophthalmic solution in reducing inflammation after routine cataract surgery. Patients reported less discomfort using 0.4% ketorolac.

Aged↗
PubMed1998

Comparison of p-fluoroketorolac and [18O3]ketorolac for use as internal standards for the determination of ketorolac by gas chromatography/mass spectrometry (GC/MS).

A chemical and a stable-isotope analog, p-fluoroketorolac and [18O3]ketorolac respectively, were directly compared for applicability as internal standards for the determination of ketorolac in plasma samples using gas chromatography/mass spectrometry (GC/MS) with selective-ion-monitoring detection, following derivatization to form the methyl esters. This comparison involved analyzing ketorolac calibration standards and spiked plasma samples that contained both internal standard candidates. The response for ketorolac and each internal standard was monitored simultaneously and electronically integrated peak heights were obtained. Thus, for each analysis performed, a response ratio was obtained for each internal standard relative to an identical ketorolac response. Linearity of response for ketorolac calibration standards and accuracy for spiked plasma sample analysis were compared using each internal standard. The use of [18O3]ketorolac as the internal standard provided superior accuracy data for the analysis of ketorolac in plasma samples.

Analgesics, Non-Narcotic↗
PubMedDate not supplied

Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group.

PURPOSE: The analgesic efficacy and safety of topical ketorolac tromethamine 0.5% ophthalmic solution (Acular) in photorefractive keratectomy was compared to its vehicle. METHODS: Double-masked, multicenter, study of 200 patients dosed with 1 drop of study medication (ketorolac or vehicle) in the operated eye immediately after surgery (eye patched), with four-times daily dosing for the next 3 days starting 3 hours after surgery. Mepergan Fortis was available as an escape pain medication. RESULTS: Patients (102) in the ketorolac group reported significantly greater pain relief and less pain intensity than the vehicle group (98) at several time points (P < or = .039). Time to first use of escape medication was significantly longer in the ketorolac than the vehicle group (mean, 16.0 vs 5.5 hr; P =.001). Time to complete pain relief was significantly shorter in the ketorolac than the vehicle group (mean, 41.3 vs 50.3 hr; P =.022). Significantly fewer patients in the ketorolac group reported sleep difficulties, ocular discomfort, or other difficulties. Few adverse events were reported with ketorolac treatment (less than with vehicle), and there were no clinically significant changes in any of the safety variables monitored. CONCLUSIONS: Ketorolac tromethamine 0.5% ophthalmic solution (Acular) is safe and significantly more effective than vehicle in alleviating pain following photorefractive keratectomy.

Adult↗
PubMed1998

Analgesic efficacy and safety of nonpreserved ketorolac tromethamine ophthalmic solution following radial keratotomy. Ketorolac Radial Keratotomy Study Group.

PURPOSE: To compare the analgesic efficacy and safety of nonpreserved ketorolac tromethamine 0.5% with those of its vehicle in the treatment of postsurgical ocular pain following radial keratotomy. METHODS: This study employed a multicenter, double-masked, randomized, parallel-group design. Radial keratotomy patients were treated with either nonpreserved ketorolac tromethamine 0.5% or its vehicle four times daily for up to 3 days following surgery. Patients were provided with an escape medication (acetaminophen) for use only as needed for intolerable pain. RESULTS: Patients treated with ketorolac reported significantly greater pain relief (P < or =.023), less pain intensity (P < or =.047), less use of escape medication (P < or =.001), fewer symptoms of ocular discomfort (P=.024), and fewer sleep disturbances (P < or =.013) than did patients treated with vehicle. No treatment-related adverse events were reported in the ketorolac group, and only one treatment-related adverse event was reported in the vehicle group. Most other safety findings were equivalent in the two treatment groups except that there were significantly less eyelid erythema (P=.026) and eyelid edema (P < or =.001) in the ketorolac group. CONCLUSIONS: Nonpreserved ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than, and as safe as, vehicle in the treatment of postoperative pain associated with radial keratotomy. Therefore, topical ketorolac may be a valuable treatment option for the maintenance of patient comfort following refractive surgery.

Adult↗
PubMed2002

A double-blind, randomized study comparing postoperative pain management using epidural ropivacaine with intravenous ketorolac or intravenous ketorolac alone following transabdominal hysterectomy.

OBJECTIVE: The aim of this study is to compare the effect on postoperative pain of epidural ropivacaine in combination with intravenous ketorolac with intravenous ketorolac alone following transabdominal hysterectomy. DESIGN: A multi-center, randomized, double-blind study was conducted in Thailand and the Philippines to assess postoperative pain management in 107 patients given ketorolac alone or in combination with epidural ropivacaine following transabdominal hysterectomy. Pain score was assessed using a 100-mm visual analogue pain scale (VAS). RESULTS: The VAS scores for pain on coughing and at rest were significantly better in the ropivacaine group. The number of patients who asked for morphine in addition was higher in the ketorolac group compared to the ropivacaine + ketorolac group. The time taken to carry out the first three ambulatory steps was similar for both the two treatment groups. A higher degree of motor block was observed in the ropivacaine group over time. The adverse events observed were similar in both groups. CONCLUSION: We demonstrated that epidural infusion of ropivacaine in addition with intravenous ketorolac gave superior pain relief at rest and on coughing in patients undergoing transabdominal hysterectomy when compared to the group receiving intravenous ketorolac alone.

Amides↗
PubMedDate not supplied

Comparison of wound infiltration with ketorolac versus intravenous regional anesthesia with ketorolac for postoperative analgesia following ambulatory hand surgery.

BACKGROUND AND OBJECTIVES: The purpose of this study was to assess the analgesic effectiveness of ketorolac administered with lidocaine via intravenous regional asesthesia (IVRA) or via wound infiltration following ambulatory hand surgery. METHODS: The patient population in this double-blind study consisted of 60 patients scheduled for elective ambulatory hand surgery, who were divided into three groups of 20 each. All patients received IVRA with 40 mL 0.5% lidocaine and 5 mL 1% lidocaine infiltrated into the surgical site. Group 1, the control group, received no additional medications; group 2 had 60 mg ketorolac added to the lidocaine used for IVRA; and group 3 had 60 mg ketorolac added to the lidocaine used for wound infiltration. Postoperative pain was assessed by a 10-cm visual analog scale. VAS) 1 hour and 2 hours after tourniquet deflation. In the postanesthesia care unit analgesia was provided with fentanyl until the VAS score reached 3 or lower. Patients were instructed to take one Tylenol No. 3 (acetaminophen with codeine) tablet every 4 hours as needed at home. They were contacted the next day, and the time to first additional narcotics and the total number of tablets taken were recoded. RESULTS: No differences in demographic variables or in operative, tourniquet, or discharge times were noted among the groups. The VAS scores were significantly lower in the two groups who received ketorolac than in the control group (P < .05); the mean time from tourniquet release to first medication was 109 +/- 73 minutes for group 1, 467 +/- 431 for group 2, and 393 +/- 312 for group 3 (P < .05); and the number of tablets taken was 4.1 +/- 1.3 for group 1, 1.8 +/- 1.2 for group 2, and 2.0 +/- 1.3 for group 3 (P < .05). CONCLUSION: Ketorolac provides similar postoperative analgesia after ambulatory hand surgery when administered with lidocaine either by IVRA or by wound infiltration.

Ambulatory Surgical Procedures↗
PubMed1994

Marked enantioselective protein binding in humans of ketorolac in vitro: elucidation of enantiomer unbound fractions following facile synthesis and direct chiral HPLC resolution of tritium-labelled ketorolac.

The protein binding of the enantiomers of the nonopiate analgesic, ketorolac, was investigated in vitro using human plasma and solutions of human serum albumin (HSA) at physiological pH and temperature. In order to detect the very low levels of unbound enantiomers in protein solutions, tritium-labelled rac-ketorolac was synthesised by regiospecific isotopic exchange of the parent drug with tritiated water as the isotope donor. Radiochemical purification of this compound by reversed-phase HPLC followed by direct resolution using a chiral alpha 1-acid glycoprotein (Chiral-AGP) HPLC column afforded labelled enantiomers of high specific activity. The in vitro use of (R)- and (S)-[3H4]ketorolac enabled reproducible radiometric detection of enantiomers in protein solution ultrafiltrate. The unbound fractions of (R)- and (S)-ketorolac [fu(R) and fu(S), respectively] were determined when drug was added to various plasma or albumin solutions as either the separate enantiomers or as the racemate. Over an enantiomeric plasma concentration range of 2.0-15.0 micrograms/ml, fu(S) (mean range: 1.572-1.795%) was more than 2-fold greater (P < 0.001) than fu(R) (mean range: 0.565-0.674%). Both fu(R) and fu(S) were constant over this concentration range, and each was unaffected by the presence of the corresponding antipode (P > 0.05). At a concentration of 2.0 micrograms/ml in 40.0 g/liter fatty acid-free HSA, fu(R) and fu(S) were approximately 0.5 and 1.1%, respectively, and both values declined with increasing concentrations of the long chain fatty acid, oleic acid.(ABSTRACT TRUNCATED AT 250 WORDS)

Analgesics, Non-Narcotic↗
PubMed2004

Pseudophakic cystoid macular edema: ketorolac alone vs. ketorolac plus prednisolone.

BACKGROUND: Pseudophakic cystoid macular edema (CME) following phacoemulsification is the most common complication after cataract surgery. Treatment focuses on the reduction of inflammation with topical use of both steroids and NSAIDS. The latter have been shown to be of benefit in chronic CME, but topical NSAID and steroid treatment has only recently been shown to be of benefit in acute CME. We evaluated the use of topically administered NSAIDS and steroids in the management of both acute and chronic pseudophakic CME. METHODS: This was a prospective double-masked randomized controlled trial. Patients with clinical CME occurring at least 6 weeks following cataract extraction were referred for consideration of enrolment. Patients were excluded if they had Snellen vision better than 20/40, no CME on clinical examination, no CME on angiography, recent use of steroids, preexisting macular disease or diabetic maculopathy on angiography. Ten patients were randomly assigned to receive either 0.5% ketorolac tromethamine plus placebo (four patients) or 0.5% ketorolac tromethamine plus 1% prednisolone acetate (six patients); all 10 completed the study. Patients were assessed at baseline and at 30, 60 and 90 days. Fluorescein angiography was performed at baseline and at 90 days. The primary outcome measures were improvement in Early Treatment Diabetic Retinopathy Study Snellen equivalent vision and resolution of cysts on clinical examination. RESULTS: No statistically significant differences were found between the two groups in either of the outcome measures at any visit. Subgroup analysis of the patients with chronic CME also showed no significant difference between the two groups. INTERPRETATION: We found no statistically significant difference in outcome between patients who received ketorolac and those who received ketorolac plus prednisolone for acute or chronic CME. The value of topical steroid therapy for chronic CME remains unproven.

Aged↗
PubMed1989

Pharmacokinetics of ketorolac and p-hydroxyketorolac following oral and intramuscular administration of ketorolac tromethamine.

Ketorolac tromethamine (KT), a potent analgesic with cyclooxygenase inhibitory activity, was administered in an open, randomized, single-dose study of Latin-square design to 12 healthy male volunteers. Doses of 30 mg oral (po) and 30, 60, and 90 mg intramuscular (im) KT were administered in solution. Plasma samples were analyzed for ketorolac (K) and its inactive metabolite, p-hydroxyketorolac (PHK), by reversed-phase high-performance liquid chromatography (HPLC). The 30-mg im dose was found to be similar to the 30-mg po dose with respect to total AUC values for both K and PHK. The amount of PHK circulating in plasma was very low as judged by AUC ratios (PHK/K x 100) of 1.9 and 1.5% for the 30-mg po and im doses, respectively. The rate of absorption of K and formation of PHK, as determined by Cmax and Tmax values, was significantly slower following the im doses. Total AUC and Cmax for K and PHK increased linearly with dose after im administration of 30, 60, and 90 mg of KT. The mean plasma half-life of K was remarkably consistent between po and im administration and was independent of dose, ranging from 5.21 to 5.56 hr. The plasma metabolic profile was similar following both routes of administration and graded im doses.

Administration, Oral↗
PubMed1997

Ketorolac. A reappraisal of its pharmacodynamic and pharmacokinetic properties and therapeutic use in pain management.

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) with strong analgesic activity. The analgesic efficacy of ketorolac has been extensively evaluated in the postoperative setting, in both hospital inpatients and outpatients, and in patients with various other acute pain states. After major abdominal, orthopaedic or gynaecological surgery or ambulatory laparoscopic or gynaecological procedures, ketorolac provides relief from mild to severe pain in the majority of patients and has similar analgesic efficacy to that of standard dosages of morphine and pethidine (meperidine) as well as less frequently used opioids and other NSAIDs. The analgesic effect of ketorolac may be slightly delayed but often persists for longer than that of opioids. Combined therapy with ketorolac and an opioid results in a 25 to 50% reduction in opioid requirements, and in some patients this is accompanied by a concomitant decrease in opioid-induced adverse events, more rapid return to normal gastrointestinal function and shorter stay in hospital. In children undergoing myringotomy, hernia repair, tonsillectomy, or other surgery associated with mild to moderate pain, ketorolac provides comparable analgesia to morphine, pethidine or paracetamol (acetaminophen). In the emergency department, ketorolac attenuates moderate to severe pain in patients with renal colic, migraine headache, musculoskeletal pain or sickle cell crisis and is usually as effective as frequently used opioids, such as morphine and pethidine, and other NSAIDs and analgesics. Subcutaneous administration of ketorolac reduces pain in patients with cancer and seems particularly beneficial in pain resulting from bone metastases. The acquisition cost of ketorolac is greater than that of morphine or pethidine; however, in a small number of studies, the higher cost of ketorolac was offset when treatment with ketorolac resulted in a reduced hospital stay compared with alternative opioid therapy. The tolerability profile of ketorolac parallels that of other NSAIDs; most clinically important adverse events affect the gastrointestinal tract and/or renal or haematological function. The incidence of serious or fatal adverse events reported with ketorolac has decreased since revision of dosage guidelines. Results from a large retrospective postmarketing surveillance study in more than 20,000 patients demonstrated that the overall risk of gastrointestinal or operative site bleeding related to parenteral ketorolac therapy was only slightly higher than with opioids. However, the risk increased markedly when high dosages were used for more than 5 days, especially in the elderly. Acute renal failure may occur after treatment with ketorolac but is usually reversible on drug discontinuation. In common with other NSAIDs, ketorolac has also been implicated in allergic or hypersensitivity reactions. In summary, ketorolac is a strong analgesic with a tolerability profile which resembles that of other NSAIDs. When used in accordance with current dosage guidelines, this drug provides a useful alternative, or adjuvant, to opioids in patients with moderate to severe pain.

Analgesics, Non-Narcotic↗
PubMed1997

Ketorolac for postoperative pain management in children.

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) with potent analgesic effects and a relatively low incidence of adverse effects. Numerous clinical trials of postoperative pain treatment in children have shown that ketorolac is as effective as the major opioid analgesics, such as morphine, and more effective than codeine. The pharmacokinetics of ketorolac differ in children compared with adult patients after surgery. In children, the volume of distribution (Vd) of ketorolac is increased by as much as 2-fold relative to that in adults. The plasma clearance (CL) of ketorolac is also higher in children, probably because of lower binding to plasma proteins. However, the elimination half-life (t 1/2 beta) of ketorolac is similar in children and adults because t 1/2 beta is directly proportional to Vd but inversely proportional to CL. These pharmacokinetic differences indicate that a higher relative dosage is required in children, but the dosage interval is similar in children and adults. Ketorolac can be administered intravenously, intramuscularly or orally. The intravenous route is preferred during the immediate postoperative period, until the patient can tolerate oral medication. Intramuscular injections are not recommended in children, unless the intravenous route is unavailable. The recommended intravenous dosage of ketorolac in children is 0.5 mg/kg, followed either by bolus injections of 1.0 mg/kg every 6 hours or an intravenous infusion of 0.17 mg/kg/h. The maximum daily dosage is 90mg, and the maximum duration of treatment is 48 hours. The recommended oral dosage is 0.25 mg/kg to a maximum of 1.0 mg/kg/day, with a maximum duration of 7 days. Older children may require somewhat lower dosages, while infants and young children may require slightly higher dosages to achieve the same level of pain relief. Ketorolac is not recommended for use in infants aged < 1 year. Unlike opioid analgesics ketorolac does not depress ventilation, and is not associated with nausea and vomiting, urinary retention or sedation. When combined with an opioid, ketorolac exhibits marked opioid-sparing effects, allowing a lower dosage of opioid to be used. Clinical studies in children and adults show that the synergistic action of ketorolac and opioids improves the degree and quality of pain relief, and reduces the incidence of opioid-related adverse effects such as respiratory depression, nausea/vomiting and ileus. Recovery of bowel function after abdominal surgery occurs sooner in ketorolac-compared with opioid-treated patients. Ketorolac reversibly inhibits cyclo-oxygenase, and decreases the hypersensitisation of tissue nociceptors that occurs with surgery. It also has reversible antiplatelet effects, which are attributable to the inhibition of thromboxane synthesis. Bleeding time is usually slightly increased, but in most patients it remains within normal values. There is conflicting evidence of the potential for increased surgical-site bleeding after tonsillectomy but, for other types of paediatric surgery, numerous clinical studies have confirmed that ketorolac is not associated with increased bleeding. Thus, ketorolac is well suited for the treatment of postoperative pain in children, either alone or in combination with opioids or local anaesthetics, because of its analgesic potency and relatively low incidence of adverse effects.

Absorption↗
PubMed1996

Chiral kinetics and dynamics of ketorolac.

It has been shown that the analgesic and cyclooxygenase inhibitor activity of ketorolac tromethamine (KT), which is marketed as the racemic mixture of (-)S and (+)R enantiomers, resides primarily with (-)S ketorolac and that the ulcerogenic activity of this agent also resides in (-)S ketorolac. Resolution of individual enantiomers for analysis in plasma samples has been accomplished by two methods: derivatization to form diastereomers that are separated by HPLC, or direct HPLC using a chiral phase column. When mice and rats were given oral solutions of (-)S and (+) KT, it was found that the kinetics and interconversion of the enantiomers were species and dose dependent. Interconversion was higher in mice than in rats; when (-)S KT was administered, 71% of the area under the concentration-time curve (AUC) was due to (+)R ketorolac in mice, compared with 12% in rats. More interconversion was observed at higher doses; the percent of AUC due to (-)S ketorolac when (+)R KT was administered increased from 12% to 25% in mice and from 2% to 8% in rats. In general, more interconversion occurred from (-)S to (+)R ketorolac in the animal studies. Human subjects were given single oral solution doses of racemic KT (30 mg), (-)S KT (15 mg), and (+)R KT (15 mg). The plasma concentrations of (-)S ketorolac were lower than (+)R ketorolac at all sample times after racemic KT (22% of the AUC was due to (-)S ketorolac). When (+)R KT was administered, (-)S ketorolac was not detectable and interconversion was essentially 0%. When (-)S KT was administered, significant levels of (+)R ketorolac were detectable and interconversion was 6.5%. After all doses, plasma half-life was shorter and clearance greater for (-)S ketorolac than for (+)R ketorolac. Thus, in humans very little or no interconversion of (+)R to (-)S was observed, and interconversion of (-)S to (+)R was minimal (6.5%). These data demonstrate that the kinetics and interconversion of the enantiomers of ketorolac is different in animals and humans as well as from most other NSAIDs. This may be due to more rapid excretion or metabolism of (-)S ketorolac and a different mechanism of interconversion.

Animals↗
PubMed1994

Evaluation of intravenous ketorolac administered by bolus or infusion for treatment of postoperative pain. A double-blind, placebo-controlled, multicenter study.

BACKGROUND: Ketorolac is a nonsteroidal analgesic that may provide postoperative analgesia without opioid-related side effects. This double-blind, randomized, multicenter study evaluated the analgesic efficacy and safety of intravenous ketorolac in 207 patients during the first 24 h after major surgery. METHODS: Subjects were assigned to receive one of three analgesic regimens: a ketorolac infusion, ketorolac boluses, or placebo. All subjects had access to intravenous morphine via patient-controlled analgesia (PCA). Evaluations included PCA morphine used, pain assessment (categorical pain intensity scores and visual analogue pain scores), pain relief (categorical pain relief scores), sedation, presence of adverse events, and overall rating of regimens by study observers and patients. RESULTS: Patients in the ketorolac infusion group (but not the ketorolac bolus group) used less morphine (average 33 mg) than did the placebo group (44 mg) (P = 0.009). Significant differences favoring both ketorolac groups were seen in the pain intensity and the categorical pain relief scores at various time points during the study. At the termination of the study, compared with the placebo group, categorical pain intensity scores were lower in the ketorolac bolus group; visual analogue pain scores were lower in both ketorolac groups; and pain relief scores were higher in the ketorolac bolus group. The incidence of vomiting was significantly greater in the placebo group (27%) than in the ketorolac infusion group (12%) or bolus group (9%) (P = 0.032 and P = 0.005, respectively). The incidence of postoperative fever was 10% in the ketorolac bolus group and 25% in the placebo group (P = 0.013). Study observers noted less nursing difficulty while caring for patients in the ketorolac infusion group (P = 0.015). Study observers and patients in both ketorolac groups reported statistically significant overall drug superiority compared with placebo. CONCLUSIONS: It is concluded that intravenous boluses or infusions of ketorolac in conjunction with PCA morphine provide effective, safe analgesia after major surgery and improve on the response to PCA morphine alone.

Adult↗
PubMed1995

Ketorolac for early postoperative analgesia.

STUDY OBJECTIVE: To determine the efficacy and speed of onset of analgesia of a single dose of intravenous (IV) or intramuscular (IM) ketorolac tromethamine following major orthopedic surgery. STUDY DESIGN: Double-blind, randomized, placebo-controlled trial. SETTING: A district general hospital in England. PATIENTS: 112 patients aged 18 to 80 years suffering moderate or severe pain following orthopedic surgery. INTERVENTIONS: Patients were randomized to receive 30 mg ketorolac IV, 30 mg ketorolac IM, or placebo following surgery. MEASUREMENTS AND MAIN RESULTS: Verbal pain intensity scores were performed prior to admission to the study, then frequently for the first 45 minutes following administration of study medication, and subsequently at hourly intervals. Times to request for further analgesia were noted. Patient assessment of overall acceptability and pain relief of the study medication was recorded. There was no statistical difference in speed of onset of analgesia between the ketorolac groups and placebo. Median (range) times to first analgesic following study drugs were: ketorolac IV 45 minutes (9 to 1440 minutes), ketorolac IM 34 minutes (10 to 1440 minutes), placebo 24 minutes (10 to 615 minutes). There was a statistically significant difference between the ketorolac groups and placebo (ketorolac IV vs. placebo, p < 0.01; ketorolac IM vs. placebo, p = 0.03). Patient assessment of overall acceptability and pain relief was significantly better for IV ketorolac compared with placebo (p < 0.01). By 6 hours, 78% of the IV ketorolac group and 95% of the IM ketorolac and placebo groups required further analgesia. CONCLUSIONS: Despite high patient acceptability compared with placebo, the use of ketorolac as the sole analgesic failed to control postoperative pain following major orthopedic surgery. IV administration of ketorolac conferred no advantages over the IM route with regard to efficacy or speed of onset.

Adolescent↗
PubMed2002

Effect of ketorolac on renal function after donor nephrectomy.

OBJECTIVES: To evaluate the safety of ketorolac, a nonsteroidal anti-inflammatory drug, that is being used more frequently for postoperative analgesia, we performed a detailed analysis of healthy patients undergoing open donor nephrectomy. METHODS: We conducted a retrospective review of 198 consecutive patients who underwent open living donor nephrectomy between January 1998 and July 2000. We compared patients who were and were not given ketorolac. Regression analysis was used to determine whether any significant interactions were present between ketorolac and donor age, sex, weight, estimated surgical blood loss, or operative time in terms of its effect on renal function. Creatinine clearance was calculated by the Gault-Cockcroft equation. RESULTS: Among the 83 patients given ketorolac, the mean amount received was 200 mg (range 30 to 360, median 210). No differences were found in the preoperative creatinine clearance between patients who did (118 +/- 29 mL/min) or did not (118 +/- 27 mL/min, P = 0.89) receive ketorolac. Patients who received ketorolac had a slightly lower creatinine clearance on the second postoperative day relative to patients who did not receive ketorolac (66% versus 72% of preoperative calculated creatinine clearance, P = 0.05). However, at a minimum of 3 months postoperatively, the creatinine clearance did not differ between the two groups (70% versus 73%, P = 0.92). Among patients who received ketorolac, no significant association was found between the amount received and renal function at any point tested. In the regression analysis, no significant interactions were found between ketorolac and the clinical variables of age, sex, weight, estimated surgical blood loss, or operative time. Moreover, in an analysis of only the patients who received ketorolac, no significant interactions were found between the amount of ketorolac received and the clinical variables of age, sex, weight, estimated surgical blood loss, or operative time. CONCLUSIONS: Ketorolac use was not associated with any long-term impairment in renal function when used during the first 2 postoperative days in healthy patients undergoing open donor nephrectomy. Moreover, in the range administered, no subset of patients or maximal ketorolac dose was identified at which ketorolac use was not safe.

Adult↗