Evaluation of intranasal midazolam in children undergoing esophagogastroduodenoscopy.

BACKGROUND: Intravenous midazolam and opioids are used to produce conscious sedation in children undergoing esophagogastroduodenoscopy (EGD). However, children may experience significant fear and anxiety before receiving these medications, especially during separation from parents and during venipuncture. Intranasal administration of midazolam represents a noninvasive method of sedating children before anxiety-producing events. The objective of this study was to determine whether premedication with intranasal midazolam reduces stress and anxiety of separation from parents and of undergoing venipuncture, while maintaining adequate sedation during EGD. METHODS: This was a prospective, randomized, double-blind study in 40 children, aged 2 to 12 years, who were undergoing EGD. Patients in group I were premedicated with intranasal placebo (0.9% NaCl) followed 10 minutes later by intravenous midazolam (0.05 mg/kg) and intravenous meperidine (1 mg/ kg). Patients in group II were premedicated with intranasal midazolam (0.2 mg/kg) followed by intravenous placebo (0.9% NaCl) and intravenous meperidine (1 mg/kg). Anxiolysis and sedation were scored by a blinded observer, who identified minor and major negative behaviors during four observation periods: intranasal drug administration, separation from parents, venipuncture, and EGD. RESULTS: Premedication with intranasal midazolam significantly reduced negative behaviors during separation from parents (p < 0.05); however, no difference between regimens was noted during venipuncture or EGD. Negative behaviors appeared to increase during administration of intranasal midazolam or placebo. CONCLUSIONS: Premedication with intranasal midazolam is effective in reducing negative behaviors during separation from parents, while it maintains sedation during the endoscopic procedure. The benefits of intranasal administration may be negated, however, by irritation, and discomfort caused by intranasal drug delivery.

Sedation with meperidine and midazolam in pediatric patients undergoing endoscopy.

We conducted a randomized, double-blind trial evaluating the efficacy and safety of meperidine 2 mg.kg-1 (M) and meperidine 2 mg.kg-1 plus midazolam 0.05 mg.kg-1 (M + M) in 40 pediatric outpatients (age 1 to 17 years) undergoing upper endoscopy procedures. The physician and nurse performing the procedure were asked to rate cooperation, emotional status, drowsiness, and overall efficacy. A blinded observer recorded the frequency of negative behaviors indicating distress, vital signs, and oxygen saturation before, during, and after the procedure. No significant differences were noted in the overall efficacy of the regimens. Good or excellent efficacy was noted in 15 of 21 children (71%) in the M group and 15 of 19 children (79%) in the M + M group by physicians; nurses assigned a good or excellent rating for 14 of 21 (67%) and 13 of 19 (68%) in the M and M + M groups, respectively. Immediately following the procedure, amnesia was noted in 4 of 17 (23%) patients who received M versus 14 of 18 (78%) patients who received M + M (P = 0.002). Of the children who received M + M, the amnesia tended to occur more frequently in older children (> 11 years, 8 children, rate of amnesia 100%) than in younger children (< or = 11 years, 6 of 10 evaluable children, rate of amnesia 60%). There was no significant difference between the frequency of negative behaviors, rate of adverse effects, or changes in vital signs or oxygen saturation noted with the two drug regimens.(ABSTRACT TRUNCATED AT 250 WORDS)

Efficacy of diazepam and meperidine in ambulatory pediatric patients undergoing endoscopy: a randomized, double-blind trial.

Medications are routinely administered to children prior to upper gastrointestinal endoscopy procedures. We evaluated the efficacy and safety of four dosage regimens: meperidine 2 mg/kg (M); low-dose meperidine 1 mg/kg and diazepam 0.1 mg/kg (M low+D); high-dose meperidine 2 mg/kg and diazepam 0.1 mg/kg (M high+D); and, diazepam 0.1 mg/kg (D) in a randomized, double-blind trial in 71 pediatric patients (ages 1 to 19 years). Cooperation, emotional state, and sedation were rated. The frequency of negative behavior demonstration (i.e., crying, gagging, flailing, nervous behavior) indicating ineffective or inadequate sedation was recorded before, during, and after the procedure. Vital signs and oxygen saturation were noted. Significant differences were observed in the efficacy of the various sedation regimens. Overall, the physicians and nurses rated M most effective in children < 11 years. In these children, M high + D and D were rated least effective by the nurses, whereas physicians felt that D was least effective. In the older children, M, M low + D, and M high + D were rated similarly effective by physicians and nurses, and D was rated least effective. In both age groups, the lowest incidence of negative behaviors during the endoscopy procedure occurred in patients who received M. Combinations of D and M + D resulted in an increased incidence of negative behaviors; thus, M may be the preferred sedation regimen in children undergoing endoscopy. The addition of diazepam to meperidine may be detrimental in terms of eliciting negative behaviors.

Efficacy and safety of a diazepam and meperidine combination for pediatric gastrointestinal procedures.

Little has been published about outpatient sedation for pediatric patients. We designed a study to evaluate the efficacy and adverse effects of diazepam and meperidine in combination for sedation in ambulatory pediatric patients undergoing endoscopy, colonoscopy, or liver biopsy. Thirty patients (7 months-20 years) were observed. Each patient received a single combined dose of intravenous diazepam and meperidine. The standard dose was 0.1 mg/kg for diazepam and 2.0 mg/kg for meperidine. In patients weighing greater than 100 lb, set doses of meperidine (100 mg) and diazepam (5 mg) were used. The time to achieve sedation and the vital signs were measured; cooperation, emotional state, and drowsiness were rated before, during, and after procedures. The amnesic effect was noted, as were any adverse effects. Diazepam and meperidine were effective in 26 of 30 patients, with sedation generally produced within 2-3 min. Cooperation and emotional state improved significantly following drug administration (p less than 0.05). When a prospective 24-h telephone follow-up study was instituted in 40 consecutive patients receiving diazepam and meperidine no significant adverse effects were noted. Only 20% of patients old enough to be questioned remembered the procedure. Diazepam and meperidine in combination appear to be effective and safe in pediatric patients undergoing gastrointestinal procedures. Prolonged monitoring of patients does not appear necessary in this patient population.