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PubMed1995

Randomized, double-blind comparison of a prochlorperazine-based versus a metoclopramide-based antiemetic regimen in patients undergoing autologous bone marrow transplantation.

BACKGROUND: Highly emetogenic combination alkylator therapy is routinely used in autologous bone marrow transplantation for treatment of eligible patients with solid tumors. Antiemetic therapy remains less than optimal in this setting. METHODS: One hundred twenty-six patients with cancer receiving high dose cisplatin, cyclophosphamide, and carmustine with autologous bone marrow support were randomized to receive one of four double-blinded antiemetic regimens: 4-day continuous infusion prochlorperazine (6 mg/m2 intravenous [i.v.] loading dose followed by 1.5 mg/m2/hour) or metoclopramide (80 mg/m2 iv loading dose followed by 20 mg/m2/hr) each with either dronabinol 5 mg/m2 or placebo capsules for two doses before carmustine on the last day of chemotherapy. All subjects received scheduled lorazepam and diphenhydramine throughout the 4-day study period. Efficacy was measured by the Emetic Process Rating Scale and the Rhodes Index of Nausea and Vomiting (INV) Form 2. RESULTS: One hundred six patients completed the study and were fully evaluable. The median number of emetic episodes on the metoclopramide study arm were: 1 (0-7, day -6), 1 (0-6, day -5), 2 (0-9, day -4), and 2 (0-10, with dronabinol day -3) or 2 (0-7, no dronabinol day -3) and on the prochlorperazine study arm were: 4 (0-12, day -6), 0 (0-8, day -5), 0 (0-12, day -4) and 2.5 (0-9, with dronabinol day -3) or 2 (0-12, no dronabinol day -3). Metoclopramide was significantly better on the first day of therapy (day -6, P < .002) and prochlorperazine was significantly better on the third day of therapy (day -4, P < 0.002). There was no significant difference among any of the four arms on the last day of chemotherapy (day -3), or when the median number of emetic episodes over the total study period were compared. The patients' assessment of nausea, vomiting, and retching on the INV Form 2 was consistent with the observer ratings. Toxicities requiring dose reduction or discontinuation of antiemetic drugs included diarrhea, cardiac arrhythmias, sedation, anxiety, and akathisia. CONCLUSIONS: Both metoclopramide and prochlorperazine in combination with lorazepam and diphenhydramine offer good control of nausea and vomiting although the sedation and low risk for cardiac toxicity limit the regimen to an inpatient setting with close monitoring. No regimen was clearly superior during the entire treatment period but prochlorperazine offered more consistent control after the first day.

Adult↗

PubMed1988

A randomized trial of oral nabilone and prochlorperazine compared to intravenous metoclopramide and dexamethasone in the treatment of nausea and vomiting induced by chemotherapy regimens containing cisplatin or cisplatin analogues.

Eighty patients receiving their first course of chemotherapy with regimens containing cisplatin or cisplatin analogues entered this open crossover study comparing nabilone 2 mg and prochlorperazine 5 mg given orally every 12 h for four doses against metoclopramide 2 mg/kg loading dose intravenously (i.v.), then 3 mg/kg as an (i.v.) infusion over 8 h and dexamethasone 20 mg (i.v.) over 3-5 min at the time of chemotherapy. There was complete control of nausea and vomiting in 24 patients (32%) given metoclopramide and dexamethasone compared to 14 patients (19%) given nabilone and prochlorperazine. For the 70 patients who completed the crossover assessment of emesis on a linear analogue scale significantly favoured metoclopramide and dexamethasone (P = 0.02). However, there was no overall patient preference for the metoclopramide and dexamethasone combination (nabilone and prochlorperazine 31 vs. metoclopramide and dexamethasone 26; 13 no preference), because a significant proportion of the patients receiving the cisplatin analogue carboplatin preferred nabilone and prochlorperazine (16 vs. 5; 1 no preference; P = 0.013). For patients receiving cisplatin chemotherapy metoclopramide and dexamethasone remains the antiemetic of choice but for regimens containing carboplatin, nabilone and prochlorperazine is better tolerated and preferred by the patients.

Adolescent↗

PubMed2004

Droperidol vs prochlorperazine for the treatment of acute headache.

To determine if droperidol i.v. is as effective as prochlorperazine i.v. in the emergency department (ED) treatment of uncomplicated headache, a randomized, controlled, blinded study was conducted in the Emergency Departments of two urban teaching hospitals. Patients >or= 18 years old with crescendo-onset headache were eligible for inclusion. Ninety-six patients (48 in each group) were randomized to receive droperidol 2.5 mg i.v. or prochlorperazine 10 mg i.v. Baseline characteristics were similar between the two study groups. For the main study outcome, 83.3% in the droperidol group and 72.3% in the prochlorperazine group reported 50% pain reduction at 30 min (p <.01; one-sided test of equivalence). The mean decrease in headache intensity was 79.1% (SD 28.5%) in the droperidol group and 72.1% (SD 28.0%) in the prochlorperazine group (p =.23). It is concluded that droperidol i.v. provided a similar reduction of headache as achieved with prochlorperazine i.v. with a similar incidence of akathisia.

Acute Disease↗

PubMed2004

Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac.

STUDY OBJECTIVE: We compare the effectiveness of intravenous ketorolac and intravenous prochlorperazine in the treatment of pediatric migraine headaches. METHODS: We performed a prospective, randomized, double-blind clinical trial in 2 pediatric emergency departments (EDs) within children's hospitals. Children aged 5 to 18 years presenting to the ED with migraine headaches were eligible for the study. Contraindications to either medication or the inability to complete the pain score resulted in exclusion. Children were randomized to receive intravenous ketorolac (0.5 mg/kg; maximum 30 mg) or intravenous prochlorperazine (0.15 mg/kg; maximum 10 mg). All children also received a normal saline solution bolus. Successful treatment was defined as a 50% or greater reduction in the Nine Faces Pain Scale score at 60 minutes. If a less than 50% improvement occurred by 60 minutes, the child received the other medication. Forty-eight-hour follow-up telephone calls were made to each family to assess recurrence and late side effects. RESULTS: Sixty-two children were enrolled: 33 initially received prochlorperazine, and 29 initially received ketorolac. By 60 minutes, 16 (55.2%) of 29 of those who received ketorolac and 28 (84.8%) of 33 of those who received prochlorperazine were successfully treated (difference=30%; 95% confidence interval [CI] 8% to 52%). Fifty-six (93.3%) of the 60 children who completed the study were successfully treated by the study's conclusion. Approximately 30% of each group had a recurrence of some headache symptoms. Only 2 children reported side effects, both mild and self-limited. CONCLUSION: In children, intravenous prochlorperazine is superior to intravenous ketorolac in the acute treatment of migraine headaches.

Adolescent↗

PubMed1994

Intravenous versus rectal prochlorperazine in the treatment of benign vascular or tension headache: a randomized, prospective, double-blind trial.

STUDY OBJECTIVE: To compare the effectiveness of i.v. and PR prochlorperazine for treatment of acute benign vascular or tension headache. DESIGN: Prospective, randomized, double-blind trial. SETTING: University emergency department with 50,000 annual census. PARTICIPANTS: Forty-five adult patients enrolled on 46 visits. INTERVENTIONS: Patients received 10 mg prochlorperazine i.v. and placebo suppository or 25 mg prochlorperazine PR and placebo injection. Pain assessment was made using a 10-cm visual-analog scale; scores were analyzed using Wilcoxon/Kruskal-Wallis rank-sum tests (alpha of .01). RESULTS: Mean 60-minute pain scores for i.v. and PR groups were 0.6 and 3.5, respectively (P = .0002). Two patients (8.7%) in the i.v. group and six patients (26.1%) in the PR group required rescue analgesia (P = .12). CONCLUSION: i.v. prochlorperazine appears to provide more effective relief than PR prochlorperazine for benign vascular or tension headaches.

Acute Disease↗

PubMed1997

Simultaneous quantitation of plasma doxorubicin and prochlorperazine content by high-performance liquid chromatography.

A high-performance liquid chromatographic method has been developed and tested for simultaneous extraction, elution and determination of doxorubicin and prochlorperazine content in human plasma samples. The procedure consists of extraction through a conditioned C18 solid-phase extraction cartridge, elution from a Spherisorb C8 reversed-phase column by an isocratic mobile phase (60% acetonitrile, 15% methanol and 25% buffer) followed by detection with electrochemical and fluorescence detectors. Recovery of doxorubicin and prochlorperazine from pooled human plasma samples (n=3) containing 100 ng/ml of the two drugs was 77.8+/-3.5% and 89.1+/-6.0%, respectively. The lower limits of quantitation for doxorubicin and prochlorperazine in plasma samples were 6.25 ng/ml and 10 ng/ml, respectively. A linear calibration curve was obtained for up to 2 microg/ml of doxorubicin and prochlorperazine. This combination method may be of particular value in clinical studies where phenothiazines such as prochlorperazine are used to enhance retention of doxorubicin in drug resistant tumor cells.

Antibiotics, Antineoplastic↗

PubMed1984

Antiemetic efficacy of dexamethasone. Randomized, double-blind, crossover study with prochlorperazine in patients receiving cancer chemotherapy.

We conducted a randomized, double-blind, crossover study comparing the antiemetic efficacy of dexamethasone and prochlorperazine in 42 patients with cancer who were receiving outpatient chemotherapy, mainly without cisplatin. Patients experienced significantly less nausea and vomiting with dexamethasone than with prochlorperazine (P less than 0.02 and less than 0.03, respectively). Twenty-five patients experienced no nausea with dexamethasone, as compared with 14 patients taking prochlorperazine (P less than 0.001). Similarly, 29 patients receiving dexamethasone did not vomit, as compared with 18 receiving prochlorperazine (P less than 0.001). Somnolence was the most frequent side effect, occurring in 60 per cent of patients receiving prochlorperazine and in 12 per cent of those receiving dexamethasone (P less than 0.001). Patients also experienced less suppression of appetite while receiving dexamethasone (P less than 0.02). We conclude that dexamethasone is an effective and safe antiemetic in patients receiving cancer chemotherapy without cisplatin.

Adult↗

PubMed2001

Intravenous administration of prochlorperazine by 15-minute infusion versus 2-minute bolus does not affect the incidence of akathisia: a prospective, randomized, controlled trial.

STUDY OBJECTIVE: We sought to compare the rate of akathisia after administration of intravenous prochlorperazine as a 2-minute bolus or 15-minute infusion. METHODS: We conducted a prospective, randomized, double-blind study in the emergency department of a central-city teaching hospital. Patients aged 18 years or older treated with prochlorperazine for headache, nausea, or vomiting were eligible for inclusion. Study participants were randomized to receive 10 mg of prochlorperazine administered intravenously by means of 2-minute push (bolus group) or 10 mg diluted in 50 mL of normal saline solution administered by means of intravenous infusion during a 15-minute period (infusion group). The main outcome was the number of study participants experiencing akathisia within 60 minutes of administration. Akathisia was defined as either a spontaneous report of restlessness or agitation or a change of 2 or more in the patient-reported akathisia rating scale and a change of at least 1 in the investigator-observed akathisia rating scale. The intensity of headache and nausea was measured with a 100-mm visual analog scale. RESULTS: One hundred patients were enrolled. One study participant was excluded after protocol violation. Seventy-three percent (73/99) of the study participants were treated for headache and 70% (70/99) for nausea. In the bolus group, 26.0% (13/50) had akathisia compared with 32.7% (16/49) in the infusion group (Delta=-6.7%; 95% confidence interval [CI] -24.6% to 11.2%). The difference between the bolus and infusion groups in the percentage of participants who saw a 50% reduction in their headache intensity within 30 minutes was 11.8% (95% CI -9.6% to 33.3%). The difference in the percentage of patients with a 50% reduction in their nausea was 12.6% (95% CI -4.6% to 29.8%). CONCLUSION: A 50% reduction in the incidence of akathisia when prochlorperazine was administered by means of 15-minute intravenous infusion versus a 2-minute intravenous push was not detected. The efficacy of prochlorperazine in the treatment of headache and nausea likewise did not appear to be affected by the rate of administration, although no formal statistical comparisons were made.

Adolescent↗

PubMed1996

Comparison of ondansetron and prochlorperazine for the prevention of nausea and vomiting after adenotonsillectomy.

This study has compared the incidences of nausea, vomiting and headache after ondansetron 0.06 mg kg-1 i.v., prochlorperazine 0.2 mg kg-1 i.m. and prochlorperazine 0.1 mg kg-1 i.v. given during induction of general anaesthesia to 282 patients undergoing adenotonsillectomy. The cardiovascular effects of the drugs were similar. After operation, nausea per se and vomiting per se occurred with similar frequency, in between 6% and 11% and 11% and 19%, respectively, in each test group. Nausea and vomiting in the same patient was reduced from 29% to 2% by i.v. ondansetron (P < 0.0005) and to 3% by i.m. prochlorperazine (P < 0.0005), and appeared to be less severe in these groups. Headache was most frequent after i.v. ondansetron (35%: P < 0.05), but occurred with similar frequency after i.m. prochlorperazine (32%) and i.v. prochlorperazine (29%).

Adenoidectomy↗

PubMed1985

A cross-over comparison of nabilone and prochlorperazine for emesis induced by cancer chemotherapy.

An anti-emetic drug, nabilone, a synthetic cannabinoid, has been compared with prochlorperazine in 24 lung cancer patients receiving cancer chemotherapy. Each of the drugs studied was given orally every 12 hours, starting the night before chemotherapy, during one of two consecutive identical chemotherapy cycles in accordance with a double-blind cross-over random order assignment. Single doses were 2 mg of nabilone, or 15 mg of prochlorperazine. The chemotherapeutic regimens given included the following drugs in various combinations: cis-platinum, vincristine, cyclophosphamide, adriamycin, vindesine, and etoposide (VP16). Nabilone was significantly superior to prochlorperazine in the reduction of vomiting episodes. Side effects, mainly vertigo, were evident in nearly half of the patients after nabilone, and three patients were withdrawn from the study due to decreased coordination and hallucinations after nabilone. Side effects from prochlorperazine were limited to mild drowsiness in one patient. Two-thirds of the patients preferred nabilone to prochlorperazine. We conclude that nabilone is a moderately effective anti-emetic drug, but that the unpredictability of its side effects call for careful patient information, especially with elderly outpatients. We recommend that at least after the first dose of nabilone, the patient should be kept under close observation during 4 hours.

Administration, Oral↗

PubMed1990

Dronabinol and prochlorperazine alone and in combination as antiemetic agents for cancer chemotherapy.

Nineteen patients receiving cancer chemotherapy were randomized in a double-blind fashion to receive either (a) dronabinol, 10 mg plus placebo q.i.d.; (b) prochlorperazine, 10 mg plus placebo q.i.d.; or (c) dronabinol plus prochlorperazine, each 10 mg q.i.d. There were six evaluable patients in each of the two single-agent groups and five in the combination group. The median duration and severity per episode of nausea was significantly greater in the group receiving prochlorperazine alone versus the other two groups. The median duration per episode of vomiting was also significantly greater in the prochlorperazine group than in the other two groups. The proportion of patients vomiting was the same in all groups; however, only one patient in the combination group versus three each in the single-agent groups experienced nausea (p = NS). The majority of side effects were associated with the CNS, including somnolence, dizziness, and confusion. Side effects were somewhat more common in both groups receiving dronabinol, though they were not statistically different from the side effects in the group receiving prochlorperazine as a single agent. Efficacy, as measured by duration of nausea and vomiting and by severity of nausea, was significantly greater in both groups receiving dronabinol.

Adult↗

PubMed1992

Abortive headache therapy in the office with intravenous dihydroergotamine plus prochlorperazine.

Over two years, 92 patients were treated in the office for 146 severe headache episodes. Headaches were aborted using four different intravenous regimens containing 0.5 or 1 mg. of dihydroergotamine and 3.5, 5, or 10 mg. of prochlorperazine. The speed and rate of response were directly proportional to the prochlorperazine dose used. High prochlorperazine doses (10 mg.) aborted the most headaches (95%) in the shortest time, but caused more sedation and akathesia. Low doses (3.5 mg.) aborted less headaches (89%) and responses were delayed; but, on the other hand, sedation was minimal and akathesia mild and uncommon. Dihydroergotamine given alone caused intolerable side effects; but, when it was given with prochlorperazine, efficacy was enhanced and side effects were greatly reduced. Aborting headaches in the office can be reliably achieved with minimal side effects by administering an intravenous mixture containing 1 mg. of dihydroergotamine and 3.5 mg. of prochlorperazine.

Adolescent↗

PubMed2006

Recirculatory pharmacokinetic model of the uptake, distribution, and bioavailability of prochlorperazine administered as a thermally generated aerosol in a single breath to dogs.

A thermal aerosol generation process is capable of delivering pure drug reliably to the alveoli where it is absorbed systemically. Although deep lung absorption of drugs administered as an aerosol has been shown to be rapid, detailed characterization of their absorption and distribution has not been reported. The present study describes the pharmacokinetics of prochlorperazine from the moment of administration as either a rapid intravenous infusion or a thermally generated aerosol and determines the bioavailability of the aerosol by two independent methods. Prochlorperazine disposition was determined in four anesthetized dogs after a 5-s intravenous infusion and after thermally generated aerosol administration in one breath. Venous blood samples were collected frequently from the time of drug administration to 24 h and left ventricular blood samples were drawn more often until 10 min after drug administration. Prochlorperazine disposition after intravenous and aerosol administration was characterized by fitting a recirculatory model to left ventricular and venous drug concentration data simultaneously. Prochlorperazine aerosol administration produced plasma drug concentrations similar to those after rapid intravenous administration of the same nominal dose, with peak left ventricular concentrations achieved in less than 30 s. Plasma concentration profiles of prochlorperazine administered by both routes were well described by the recirculatory model. Bioavailability of the thermally generated aerosol was consistent and averaged more than 80% of emitted dose. Pulmonary administration of a thermally generated drug aerosol in one breath may be a viable alternative to rapid intravenous administration of drugs requiring rapid and predictable production of effective plasma concentrations.

Aerosols↗

PubMedDate not supplied

Double-blind comparison of the antiemetic effects of nabilone and prochlorperazine on chemotherapy-induced emesis.

The antiemetic effect of oral nabilone, a synthetic cannabinoid, given at a dose of 2 mg every 12 hours was compared to oral slow-release capsules of prochlorperazine given at a dose of 10 mg every 12 hours by a double-blind crossover method in 37 patients receiving cancer chemotherapy. Patients received one of the following as the primary emetic stimulus: high-dose cis-dichlorodiammineplatinum(II) (DDP), low-dose DDP, mechlorethamine, streptozotocin, actinomycin D, or DTIC. Although results varied according to strength of emetic stimulus received, both nabilone and prochlorperazine appeared to produce antiemetic effects. Eighteen of the 37 patients achieved a complete or partial elimination of symptoms: seven with nabilone alone, three with prochlorperazine alone, and eight with each drug. Nabilone appeared to be the more effective antiemetic for patients who received chemotherapy agents other than high dose DDP; it was equivalent to prochlorperazine for those who did receive high-dose DDP. Side effects from prochlorperazine were limited to mild drowsiness occurring among 35% of the patients. The side effects from nabilone were drowsiness and dizziness which occurred frequently and were dose-limiting in 25% of patients.

Adult↗

PubMedDate not supplied

Antiemetic effect of perphenazine versus prochlorperazine intravenously before cisplatin therapy.

Antiemetic effects of perphenazine and prochlorperazine, both administered by continuous i.v. infusion after a loading dose, were compared in patients receiving cisplatin. Study subjects were 6 men and 13 women for whom other antiemetic therapy had failed; each patient was studied during two courses of cisplatin therapy. Patients were randomly selected to receive either perphenazine or prochlorperazine during the first course; for the second course, each received the other antiemetic. During drug administration, nausea, retching, vomiting, and side effects of the antiemetic were recorded hourly by the patient and concurrently by a pharmacist observer (both blinded). Each patient's scores on nausea, retching, and vomiting were compared by drug and by treatment sequence. Evaluable data for 17 patients showed that aggregate differences between responses to the two drugs were not significant. Fourteen patients had significantly less nausea, retching, and vomiting during the second course of treatment. Few side effects were reported. Nervousness was experienced with prochlorperazine in four patients and perphenazine in one, and drowsiness occurred with prochlorperazine in four patients and perphenazine in three. Perphenazine and prochlorperazine, when given in equal doses and administered by continuous i.v. infusion after a loading dose, were equally effective in controlling nausea and vomiting associated with cisplatin therapy.

Adult↗

PubMed1984

Double-blind multiple-dose crossover study of the antiemetic effect of intramuscular levonantradol compared to prochlorperazine.

Twenty cancer patients who received chemotherapy were entered into a double-blind crossover design antiemetic study comparing 1 mg levonantradol, an investigational synthetic cannabinoid, to 10 mg prochlorperazine. Sixteen patients completed the crossover. For each antiemetic course, four doses of each study medication were given intramuscularly 2 hours before chemotherapy and then 2, 6, and 10 hours after chemotherapy administration. There were no statistical differences in patients' responses to levonantradol and prochlorperazine. The frequency of side effects was greater with levonantradol than with prochlorperazine. The most common side effect of levonantradol were somnolence, dry mouth, dizziness, tachycardia, postural hypotension, and blurred vision, while those for prochlorperazine were somnolence, dry mouth, and tachycardia.

Adolescent↗

PubMed1989

A dose finding study of prochlorperazine as an antiemetic for cancer chemotherapy.

This phase I study determined the maximum tolerated dose of prochlorperazine when used as an antiemetic prior to cytotoxic chemotherapy. Initially, cohorts of three patients were given prochlorperazine at escalating doses of 0.2, 0.4, 0.6, 0.8, 1.0 and 1.2 mg/kg as an intravenous infusion over 20 min. The maximum tolerated dose was 1.2 mg/kg. The dose-limiting toxicity was hypotension which was reversed by a fluid load. The other major toxicities were extrapyramidal reactions which were dose related. All patients at the 1.2 mg/kg dose reported restlessness while five of six were restless and two of six at 1.0 mg/kg had muscle spasms. Two of seven patients reported restlessness at the 0.8 mg/kg level. Sedation and dry mouth were reported at all dose levels but were more common at higher doses. Prochlorperazine in plasma was assayed by high performance liquid chromatography with electrochemical detection and pharmacokinetics were determined for three patients at the 1.0 mg/kg dose level. The average terminal elimination half life was 7.6 +/- 0.4 h, plasma clearance 27 +/- 5 ml/min/kg and volume of distribution 17.7 +/- 4.5 l/kg. The dose of prochlorperazine recommended for further studies of antiemetic efficacy is 0.8 mg/kg intravenously.

Antiemetics↗

PubMed1991

Dronabinol and prochlorperazine in combination for treatment of cancer chemotherapy-induced nausea and vomiting.

Dronabinol (Marinol, Roxane Laboratories, Columbus, OH) and prochlorperazine were tested alone and in combination in a randomized, double-blind, parallel group, multicenter study. Patients were randomized to receive either 1) dronabinol 10 mg every 6 hr plus placebo; 2) placebo plus prochlorperazine 10 mg every 6 hr; or 3) dronabinol and prochlorperazine, each 10 mg every 6 hr. Antiemetic treatment was begun 24 hr prior to and continued for 24 hr after the last dose of chemotherapy; all was given orally. Only 29% of patients in group 3 versus 47% in group 1 and 60% in group 2 experienced nausea after chemotherapy. In addition, the median duration per episode and severity of nausea were significantly less with combination therapy. Vomiting occurred after chemotherapy in 41%, 55%, and 35% of patients in groups 1, 2, and 3, respectively. The median duration per episode of vomiting was 1 min in group 3 versus two in group 1 and four in group 2. Side effects, primarily CNS, were more common in group 1 than in group 2; addition of prochlorperazine to dronabinol appeared to decrease the frequency of dysphoric effects seen with the latter agent. The combination was significantly more effective than was either single agent in controlling chemotherapy-induced nausea and vomiting.

Adult↗