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Placebo-controlled trial assessing the use of oral midazolam as a premedication to conscious sedation for pediatric endoscopy.

BACKGROUND: This study was performed to evaluate the effect of midazolam, as premedication before intravenous conscious sedation, on preprocedural, procedural, and post-procedural patient comfort and anxiety in children undergoing endoscopy. METHODS: A placebo-controlled, double-blind, randomized study was conducted in 123 children (age 7.75 +/- 4.46 years, 56% male) using oral midazolam (0.5 mg/kg, maximum 20 mg) as a premedication before insertion of an intravenous access device (i.v.) and upper endoscopy. Patients were evaluated with regard to changes in vital signs, level of sedation during i.v. placement, level of pre- and post-procedure conscious sedation, ease of separation from parents, ease and duration of procedure, recovery time, and amnesia to objects shown before i.v. placement and immediately before the start of the procedure. RESULTS: A significant difference was noted in the study group for the following parameters: level of sedation for i.v. placement (p < 0.0001), pre-procedural sedation (p < 0.001), ease of i.v. insertion (p < 0.003), ease of separation from parents (p = 0.022), and ease of the nursing personnel's ability to monitor the patient during the procedure (p = 0.0012). The patient's amnesia to an object shown immediately before beginning the endoscopy was increased (p < 0.001). Patients and parents were also more satisfied with the procedure process (p < 0.05). No significant difference was noted with regard to the length or performance of the procedure or recovery time or in the dose of i.v. medication required for successful completion of the endoscopy. CONCLUSION: Oral midazolam is an effective and safe premedication for children undergoing upper endoscopy and should be used in all anxious children and in patients previously judged to be difficult to sedate.

Administration, Oral↗

A randomized double-blind placebo-controlled trial evaluating the cost-effectiveness of droperidol as a sedative premedication for EUS.

BACKGROUND: Droperidol is a neuroleptic agent with anti-emetic properties that produces mild sedation, reduced anxiety, and a state of mental detachment and indifference to one's surroundings. Routine premedication with droperidol has been shown to improve sedation during esophagogastroduodenoscopy and endoscopic retrograde cholangiopancreatography. The purpose of this randomized double-blind placebo-controlled study was to determine whether premedication with droperidol improves sedation during routine upper endoscopic ultrasound (EUS) in a cost-effective manner. METHODS: One hundred consecutive patients referred for EUS were randomly assigned to receive either 2.5 mg or 5 mg of droperidol or placebo before the procedure. After EUS, the physician, nurse, and recovered patient scored various parameters of procedural sedation. RESULTS: In the group receiving 5 mg of droperidol there was significantly less gagging at intubation, less retching during the procedure, better patient cooperation, less need for physical restraint, and improved nurses' and physician's impression of sedation. Significantly less meperidine and less midazolam were required for sedation, making medication costs significantly lower in the group receiving 5 mg droperidol. CONCLUSIONS: A 5 mg dose of droperidol given as premedication for routine upper EUS improves sedation during the procedure while significantly decreasing the overall cost of sedation.

Adjuvants, Anesthesia↗

Benefit of intravenous antispasmodic (hyoscyamine sulfate) as premedication for colonoscopy.

BACKGROUND: We sought to determine whether premedication for colonoscopy with intravenous hyoscyamine sulfate (Levsin) was helpful from the standpoint of the colonoscopist and the patient. METHODS: One hundred sixteen adult patients were randomized to receive either 0.5 mg hyoscyamine sulfate intravenous (n = 57) or placebo (n = 59). After administration of study drug, patients were given meperidine and midazolam. Parameters measured included the time required to reach the cecum, total procedure time, and the endoscopist's perception of the adequacy of sedation, difficulty of insertion, and amount of colonic spasm on insertion and withdrawal. Patients were given a postprocedure questionnaire assessing their experience. RESULTS: In patients receiving hyoscyamine, there was a shorter cecal intubation time (median 9.2 vs. 12.9 minutes; p = 0. 01), shorter total colonoscopy time (median 20.5 vs. 25.0 minutes; p = 0.01), better patient sedation (p = 0.02), easier colonic insertion (p = 0.001), and less spasm on insertion (p = 0.01). No difference was found in the amount of spasm during withdrawal or the total dosages of meperidine or midazolam used. Patients receiving hyoscyamine sulfate reported being more comfortable during their procedures ( p < 0.001) and were more willing to repeat colonoscopy in the future (p = 0.0001). The only adverse effect seen during the study was a 27% incidence of sinus tachycardia that occurred in patients receiving hyoscyamine. CONCLUSIONS: Premedication with intravenous hyoscyamine sulfate was beneficial in terms of the time required for cecal intubation, total procedure time, adequacy of sedation, and scales of patient comfort. However, the high frequency of sinus tachycardia seen with the dose used in our study, which was extremely rapid in two patients, indicates the need for further study before the drug can be recommended as a routine premedication for colonoscopy.

Adolescent↗

The effectiveness of premedication for endotracheal intubation in mechanically ventilated neonates. A systematic review.

IMPLICATIONS FOR PRACTICE: Extrapolating information from the adult and pediatric literature suggests that awake intubation is probably inappropriate in most neonates. Because premedication attenuates the physiologic responses to intubation, its use is recommended. Adequately skilled staff who have a full understanding of the potential benefits and harms of the interventions used should perform intubation and the administration of premedication in neonates. IMPLICATIONS FOR RESEARCH: There is a need for well-designed and well-executed randomized controlled trials assessing the effectiveness and potential adverse effects of premedicated intubation in neonates. A valid pain assessment measure or approach should be used. Both short-term and long-term physiologic and clinical outcomes should be incorporated into the trial design.

Analgesics↗

The influence of premedication on heart rate variability.

Analysis of heart rate variability has been used to study the effects of midazolam, morphine and clonidine on the autonomic nervous system, when administered to patients for premedication. Ninety-five patients were studied 60 min before and 60 min after premedication. Normal saline (n = 25), midazolam 0.08 mg.kg-1 (n = 24), morphine 0.15 mg.kg-1 (n = 23), or clonidine 2 micrograms.kg-1 (n = 23) were administered intramuscularly by random allocation. A Holter device was connected to the patient during the study period. Using power spectral analysis the low-frequency and high-frequency components were calculated from the Holter recordings. These are markers for sympathetic and parasympathetic activity respectively; the low- to high-frequency ratio was also calculated, a ratio of > 1 signifying sympathetic dominance. A significant reduction was noticed in both low-frequency and high-frequency power in the three premedicated groups, whereas no changes were observed in the normal saline group. In the case of midazolam, both the low and high frequencies were decreased but the low- to high-frequency ratio did not change significantly. Morphine and clonidine depressed the low-frequency component more than the high-frequency component and the low- to high-frequency ratio was decreased, suggesting parasympathetic dominance. We conclude that heart rate variability may be a useful tool for investigating the effect of drugs on the autonomic nervous system.

Adrenergic alpha-Agonists↗

A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy.

BACKGROUND AND STUDY AIMS: The study tested whether pronase can improve endoscopic visibility and alter the accuracy of the CLO test for H. pylori detection. PATIENTS AND METHODS: A total of 160 patients were randomly assigned to receive one of five premedications for endoscopy: group A: dimethylpolysiloxane (DMPS) alone; group B: DMPS plus water (up to 100 ml); group C: pronase only, with 100 ml water; group D: pronase and sodium bicarbonate plus water up to 100 ml; group E: pronase, sodium bicarbonate, and DMPS, plus water up to 100 ml. Endoscopists, who were unaware of the premedication method administered, assessed visibility scores (range 1 - 4) for the antrum, lower gastric body, upper gastric body, and fundus. The higher the score, the less clear the visibility. The sum of scores from the four locations was defined as the total visibility score. A CLO test was also done during the endoscopy. One week after their endoscopy, patients in groups C, D, and E were scheduled for a (13)C-urea breath test (UBT). RESULTS: Group E patients had a significantly lower total visibility score than those in the other four groups ( P < 0.05). Groups C and D had higher total visibility scores than the other three groups ( P < 0.05). The scores did not significantly differ between groups A and B. Based on the UBT results, the sensitivity and specificity of the CLO test were 92.6 % and 96.2 %, respectively. CONCLUSIONS: Premedication as in group E provided the clearest endoscopic visibility. Without the application of DMPS, pronase alone cannot improve endoscopic visibility. Pronase does not influence H. pylori identification using the CLO test.

Adult↗

Intravenous hyoscine as a premedication for colonoscopy: a randomized double-blind controlled trial.

BACKGROUND AND STUDY AIMS: There is wide variation in the use of antispasmodics to facilitate colonoscopy, both within and between countries, and its use before such procedures remains controversial. The aim of this study was to determine whether there was any objective benefit in using hyoscine as a premedication for colonoscopy in a district general hospital. PATIENTS AND METHODS: Consecutive day-case patients undergoing colonoscopy were included in the study. They were prospectively randomly allocated to receive either intravenous hyoscine (n = 61) or intravenous placebo (n = 56) as part of their premedication. RESULTS: Our analysis demonstrated no statistically significant difference between the two groups with respect to the median time from colonoscope insertion to caecal intubation (9.7 minutes in the hyoscine group vs. 8.3 minutes in the placebo group) or the median total procedure time (14.8 minutes in the hyoscine group vs. 13.8 minutes in the placebo group). There was also no statistically significant difference in success rates for caecal intubation between the two groups ( P < 0.06). However a type II error cannot be excluded because of the small sample size. CONCLUSION: This study demonstrated no obvious benefit in the routine use of hyoscine as a premedication for colonoscopy in a district general hospital setting.

Adult↗

Diazemuls versus diazepam as premedication in upper gastrointestinal endoscopy: a randomised cross-over study.

The efficacy and tolerability of Diazemuls versus conventional diazepam as endoscopic premedication was evaluated in a study with a cross-over design performed in 26 patients undergoing upper gastrointestinal tract endoscopy. No statistically significant differences were found between the two forms of premedication with regard to degree of sedation, patient compliance or recovery of psychomotor function. With respect to short-term amnesic effects, efficacy and tolerability Diazemuls was comparable to the conventional formulation of diazepam. Diazemuls may therefore be proposed as an alternative premedication for endoscopy.

Adult↗

Premedication for neonatal intubation.

The incidence of complications was recorded for 269 consecutive neonatal endotracheal intubations after instituting a routine policy of premedication. Two hundred and fifty-three of the intubations were premedicated with a combination of atropine, fentanyl and succinylcholine, 194 were without incident, 28 required two attempts, 22 required more than two attempts, and 9 required a second attempt with a smaller endotracheal tube. All infants were successfully intubated. We conclude that a policy of routine neonatal premedication for intubation is safe, feasible, and humane.

Adjuvants, Anesthesia↗

Medical-themed film and literature course for premedical students.

The authors introduced a "Medicine and Literature" course into the premedical curriculum to help students develop clearer expectations regarding their lives as future physicians, and also to gain insight into the humanistic and social aspects of medicine. The course was developed for the entire class of second-grade premedical students (n = 126) and consisted of one three-hour session per week over six weeks. The course was composed of two main themes: (1) medicine and film; and (2) medicine and literature. Students' responses showed that this course helped them to gain perspectives on both a physician's life and medical practice, and also enhanced their understanding of the humanistic and social aspects of medicine itself. Students reported that they also valued the advantages of collaborative learning, which holds the potential for improving their skills in presentation, discussion, communication and teamwork. In Korea, introducing arts- and humanities-related courses into the medical curriculum is a recent trend, and is still in a very early stage. Although our study has several limitations, we conclude that by studying literature and films during the premedical period, students can grasp a sense of the many different issues that physicians are faced with.

Curriculum↗

Dose of propofol for laryngeal mask airway insertion in children: effect of premedication with midazolam.

We determined the dose-response curves and effective doses of propofol for insertion of the laryngeal mask airway (LMA) in 50 unpremedicated children and in 60 children premedicated with midazolam, aged 3-12 yr. One of several doses of propofol was administered i.v. over 15 s to groups of 10 children, and conditions for LMA insertion were assessed at 60 s. The dose-response curves were parallel (P = 0.94), but the curve for premedicated children was shifted significantly to the left of that for unpremedicated children and propofol requirements were reduced by one-third (P < 0.0001). The doses required for satisfactory LMA insertion in 50% and 90% of unpremedicated patients (ED50, ED90) (95% confidence interval) were 3.8 (3.4-4.2) mg kg-1 and 5.4 (4.7-6.8) mg kg-1, respectively; those for premedicated patients were 2.6 (2.2-2.8) mg kg-1 and 3.6 (3.2-4.3) mg kg-1, respectively.

Anesthetics, Intravenous↗

Atropine premedication and the cardiovascular response to electroconvulsive therapy.

A report by the Royal College of Psychiatrists recommended avoiding atropine premedication during electroconvulsive therapy (ECT). We have examined the cardiovascular effects of ECT with or without atropine premedication. Consenting patients (n = 30) were allocated randomly before their third ECT session to receive atropine or no premedication. The rate pressure product (RPP) was recorded before anaesthesia, before ECT stimulus and at 1-min intervals thereafter for 5 min. Patients who did not receive atropine had significantly lower RPP values after all stimulus recordings. Administration of atropine or not explained 32% of the variance of summated RPP after the stimulus. There was no clinically significant bradyarrhythmia in those who did not receive atropine. Our findings support the recommendation of the Royal College of Psychiatrists. The study suggests that when threshold determination is not needed, avoiding atropine effectively contains potentially harmful cardiovascular responses.

Adjuvants, Anesthesia↗

The effect of clonidine premedication on hemodynamic responses to microlaryngoscopy and rigid bronchoscopy.

The usual hemodynamic response to laryngoscopy and bronchoscopy is an increase in heart rate and arterial blood pressure. Previous work has reported that 10%-18% of the patients develop ischemic ST segment changes during the procedure. Therefore, we performed a prospective, randomized, double-blinded study in 36 patients scheduled for elective microlaryngeal and bronchoscopic surgical procedures to evaluate the effects of 300-microg oral clonidine premedication (n = 18) or placebo (n = 18) on the hemodynamic alterations and the incidence of perioperative myocardial ischemic episodes. Myocardial ischemia was assessed by using continuous electrocardiographic monitoring, beginning 30 min before, and lasting until 24 h after the operation. During the procedure, patients receiving placebo exhibited a significant increase (mean +/- SD) in arterial blood pressure (the systolic increasing from 137+/-11 to 166+/-17 mm Hg, the diastolic increasing from 80+/-11 to 97+/-14 mm Hg) and heart rate (increasing from 79+/-15 to 97+/-12 bpm) compared with the baseline and with the clonidine group. A dose of 300-microg clonidine blunted the hemodynamic response to endoscopy. Ventricular arrhythmias were more frequent in patients who were not premedicated with clonidine. Two patients in the control group, but none in the clonidine group, had evidence of myocardial ischemia. These data should encourage routine premedication with clonidine in patients undergoing microlaryngoscopic and bronchoscopic procedures.

Adrenergic alpha-Agonists↗

Gastroesophageal reflux and tracheal aspiration in the thoracotomy position: should ranitidine premedication be routine?

UNLABELLED: Aspiration of gastric contents may contribute to pulmonary complications after thoracotomy. The incidence of gastroesophageal reflux (GER) and tracheal acid aspiration in patients undergoing thoracotomy in the lateral position is unknown. Ranitidine premedication reduces gastric volume, increases gastric pH, and may reduce GER. We used continuous intraluminal esophageal and tracheal pH monitoring probes to investigate the effect of ranitidine on the incidence of GER and tracheal aspiration in 80 adult patients undergoing thoracotomy. The study was placebo-controlled, randomized, and double-blinded. Patients at high risk of GER were excluded from the study. The incidence of acid GER in the placebo and ranitidine groups was 28.2% and 2.5%, respectively (P = 0.006). Multiple episodes of GER occurred in some patients in the placebo group only. The total number of episodes of GER in the placebo and ranitidine groups was 16 and 1, respectively (P = 0.002). The incidence of tracheal acid aspiration in the placebo and ranitidine groups was 7.7% and 2.5%, respectively (not significant). Patients undergoing thoracotomy are therefore at high risk of acid GER, which may lead to tracheal acid aspiration in an appreciable proportion. Premedication with ranitidine significantly reduces, but does not eliminate, the incidence of this potentially life-threatening complication. IMPLICATIONS: Gastroesophageal reflux (GER) and tracheal aspiration of acid may increase morbidity and mortality in patients undergoing thoracotomy. This randomized, double-blinded, placebo-controlled study demonstrates frequent incidences of both acid GER and tracheal acid aspiration during surgery that are significantly reduced by premedication with ranitidine.

Double-Blind Method↗

Participation in a premedical summer program for underrepresented-minority students as a predictor of academic performance in the first three years of medical school: two studies.

PURPOSE: To determine whether the performances of underrepresented minority students in the Medical Education and Development Program (MEDP) at the University of North Carolina Chapel Hill (UNC-CH) School of Medicine (a structured, nine-week summer premedical program that simulates the medical school's first year curriculum) predicted their academic performances in the first three years of medical school. METHOD: These two studies looked separately at the predictive value of students' rankings (top quarter or top half) within their MEDP cohorts. The first study involved 165 students who had participated in the MEDP from 1981 to 1990 and who then matriculated at UNC-CH. Using backward elimination logistic regression models, the author determined whether those rankings and other, more traditional academic performance predictors predicted three types of academic difficulty during the first two years of medical school: (1) required participation in summer review; (2) deceleration; and (3) dismissal. The predictive validity of each regression model was assessed by calculating the sensitivity and the positive predictive value. The second study involved 135 students who had participated in the MEDP from 1981 to 1990 and who had finished their third-year clinical clerkships at UNC-CH. Forty-four of those students had taken the National Board of Medical Examiners (NBME) Part II examination. Using Spearman correlations, the Student t test, and the chi-square test, the author determined the simple relationships among MEDP ranking, traditional premedical academic predictors, and third-year clinical performance (as measured by clerkship grades and NBME scores). The author determined the best predictors of third-year clinical performance using stepwise backward-elimination linear regression models. RESULTS: In both studies, a student's ranking within his or her MEDP cohort was the strongest, if not the only, predictor of medical school academic performance. CONCLUSION: These studies suggest that structured summer premedical programs such as UNC-CH's MEDP are quite good at determining whether participants will be able to handle the academic rigors of medical school.

Clinical Clerkship↗

Buprenorphine as premedication and as analgesic during and after light isoflurane-N2O-O2 anaesthesia. A comparison with oxycodone plus fentanyl.

Sixty patients undergoing gynaecological laparotomies under isoflurane anaesthesia received 0.4 mg of buprenorphine sublingually or 0.12 mg/kg of oxycodone intramuscularly in random order for preanaesthetic medication. Patients premedicated with buprenorphine were given buprenorphine before, during and after anaesthesia and patients premedicated with oxycodone received fentanyl before and during anaesthesia and oxycodone after anaesthesia. Buprenorphine premedication produced less drowsiness and sedation and alleviated patients' apprehension significantly (P less than 0.05) less than oxycodone. Systolic and diastolic blood pressure and heart rate were significantly (P less than 0.05 to P less than 0.01) higher after intubation in the buprenorphine group when compared with the oxycodone plus fentanyl group. After anaesthesia, spontaneous respiration started rapidly; the return of consciousness and immediate recovery occurred at the same rate in both groups. In the recovery room moderate to severe pain was more common (P less than 0.05) in the oxycodone plus fentanyl group than in the buprenorphine group. The respiratory rate in the recovery room was lower among patients given buprenorphine, and two patients given buprenorphine developed severe respiratory depression. In the ward (2 to 24 h after operation) sublingual buprenorphine provided pain relief as good as intramuscularly administered oxycodone. No differences were noted in the incidence or severity of emetic symptoms between the groups. It is concluded that buprenorphine can provide good postoperative pain relief for gynaecological laparotomies performed under light isoflurane anaesthesia, but patients need to be monitored carefully after operation because of the possibility of respiratory depression.

Adult↗

Premedication with intravenous ketorolac trometamol (Toradol) in colonoscopy: a randomized controlled trial.

OBJECTIVE: We conducted a prospective double-blinded placebo-controlled randomized trial to investigate the effect of ketorolac trometamol (KT) administered intravenously as premedication in colonoscopy. METHODS: One hundred and forty patients undergoing colonoscopy were randomized to receive either 60 mg of KT (KT group (KTG), n=70) or placebo (normal saline group (NSG), n=70) intravenously as premedication 30 min prior to procedure. Patient-controlled sedation (PCS) was used as the mode of sedation. Outcome measures included patient self-assessed pain score in a 10-cm unscaled visual analog scale (VAS), endoscopist assessment of patient pain score in VAS, patient's willingness to repeat colonoscopy, administered and demanded doses of PCS, patient satisfaction score in VAS, and hemodynamic changes during and after the procedure. RESULTS: The mean patient self-assessed pain score (SD) during procedure was significantly lower in KTG than NSG: 5.08 (2.74) vs 6.62 (2.45); p=0.001. The mean endoscopist assessment of patient pain score (SD) was significantly lower in KTG than NSG as well: 3.99 (2.80) vs 5.28 (2.71); p=0.006. More patients in KTG were willing to repeat procedure as compared with NSG (80.0%vs 57.1%; p=0.004). No significant difference was found in the administered and demanded doses of PCS, mean satisfactory scores and hemodynamic changes in both groups. No serious complication related to intravenous (IV) KT was noted. CONCLUSIONS: Premedication with IV KT (Toradol) improves pain control during colonoscopy with no associated serious complications.

Academic Medical Centers↗

Oral premedication with low dose midazolam modifies the immunological stress reaction after the setting of retrobulbar anaesthesia.

BACKGROUND/AIMS: An acute immunological stress reaction was previously reported to occur after the painful setting of retrobulbar anaesthesia before intraocular surgery. This study was conducted to find out whether an oral low dose premedication with midazolam would modify the immunological stress reaction. METHODS: 32 patients undergoing intraocular surgery using retrobulbar anaesthesia were included in a randomised, double blind trial. They received premedication with either 3.75 mg midazolam or placebo 30 minutes before the retrobulbar injection. Counts of leucocyte subpopulations, cardiovascular, and psychometric parameters were measured repetitively before and after the retrobulbar injection. RESULTS: The numbers of leucocytes increased significantly in the placebo group after the setting of retrobulbar anaesthesia (before retrobulbar injection: 6687 (SD 1025) cells x10(6)/l; after injection: 7067 (1022) cells x10(6)/l, p=0.0009) caused by rising numbers of neutrophils (before injection: 4111 (1063) cells x10(6)/l; after injection: 4352 (1147) cells x10(6)/l, p=0.0007) and natural killer cells (before injection: 290 (84) cell x10(6)/l; after injection 354 (133) cells x10(6)/l, p=0.003). There was no significant increase in total leucocytes (before injection: 5997 (1288) cells x10(6)/l; after injection: 6189 (1215) cells x10(6)/l) or in any leucocyte subpopulation in the midazolam group. A significant rise in systolic blood pressure occurred in the placebo group, but not in the midazolam group. CONCLUSION: A low dose premedication with midazolam attenuates the immunological and cardiovascular stress reactions occurring with retrobulbar anaesthesia.

Aged↗