STUDY OBJECTIVES: We studied the hypothesis that rectal thiopental is an effective agent for emergency department pediatric sedation and may have advantages over a more traditional regimen. DESIGN:Rectal thiopental25 mg/kg was compared with the combination of meperidine 2 mg/kg, promethazine 1 mg/kg, and chlorpromazine 1 mg/kg in a prospective, randomized, double-blinded study. TYPE OF PARTICIPANTS: Children between 18 months and 6 years of age presenting to our teaching hospital ED for laceration repair were entered after the clinical decision was made to sedate. Patients with altered sensorium, medical contraindications to sedation, or medication allergy were excluded. INTERVENTIONS: After informed consent, each patient received IM injection (drug combination or placebo) and rectal suspension (rectal thiopental or placebo) simultaneously. MEASUREMENTS AND MAIN RESULTS:Vital signs, pulse oximetry, and pediatric Glasgow Coma Scores were recorded before and every 15 minutes after sedation until discharge. Intradermal lidocaine and suturing began when the patient appeared adequately sedated, and response was numerically scored. Patients were discharged when able to stand. Twenty-nine patients 34 +/- 13 months old were studied. Fifteen patients received rectal thiopental, and 14 received the drug combination. Analysis using the Wilcoxon two-sample test revealed no differences in age, sex, weight, or wound location between groups. The time course of sedation was different for the two treatment regimens. At 15 and 30 minutes after administration, patients who received rectal thiopental were more deeply sedated than those who received the drug combination, as evidenced by significantly lower Glasgow Coma Scores (P less than .05). Accordingly, time from medication administration to suturing was 29 +/- 12 minutes in the thiopental group and 54 +/- 33 minutes (P less than .01) in the drug combination group. Patients in the thiopental group also recovered more quickly and were discharged approximately one-half hour earlier than those in the drug combination group (89 +/- 25 vs 120 +/- 44 minutes, P less than .05). No difference in response to lidocaine injection or suturing was demonstrated between the groups. Laceration repair time was comparable between the groups. There were eight sedation failures (three of 15 in thiopental group and five of 14 in drug combination group, P = NS). Vital signs remained stable, no adverse reactions occurred, and no patient had decreased oxygen saturation to less than 95%. CONCLUSION:Rectal thiopental is superior to this drug combination for pediatric sedation because it can be administered painlessly, has a more rapid onset and offset of action, and is of equal safety and efficacy at the dosage studied.
RCT Entities:
STUDY OBJECTIVES: We studied the hypothesis that rectal thiopental is an effective agent for emergency department pediatric sedation and may have advantages over a more traditional regimen. DESIGN: Rectal thiopental 25 mg/kg was compared with the combination of meperidine 2 mg/kg, promethazine 1 mg/kg, and chlorpromazine 1 mg/kg in a prospective, randomized, double-blinded study. TYPE OF PARTICIPANTS: Children between 18 months and 6 years of age presenting to our teaching hospital ED for laceration repair were entered after the clinical decision was made to sedate. Patients with altered sensorium, medical contraindications to sedation, or medication allergy were excluded. INTERVENTIONS: After informed consent, each patient received IM injection (drug combination or placebo) and rectal suspension (rectal thiopental or placebo) simultaneously. MEASUREMENTS AND MAIN RESULTS: Vital signs, pulse oximetry, and pediatric Glasgow Coma Scores were recorded before and every 15 minutes after sedation until discharge. Intradermal lidocaine and suturing began when the patient appeared adequately sedated, and response was numerically scored. Patients were discharged when able to stand. Twenty-nine patients 34 +/- 13 months old were studied. Fifteen patients received rectal thiopental, and 14 received the drug combination. Analysis using the Wilcoxon two-sample test revealed no differences in age, sex, weight, or wound location between groups. The time course of sedation was different for the two treatment regimens. At 15 and 30 minutes after administration, patients who received rectal thiopental were more deeply sedated than those who received the drug combination, as evidenced by significantly lower Glasgow Coma Scores (P less than .05). Accordingly, time from medication administration to suturing was 29 +/- 12 minutes in the thiopental group and 54 +/- 33 minutes (P less than .01) in the drug combination group. Patients in the thiopental group also recovered more quickly and were discharged approximately one-half hour earlier than those in the drug combination group (89 +/- 25 vs 120 +/- 44 minutes, P less than .05). No difference in response to lidocaine injection or suturing was demonstrated between the groups. Laceration repair time was comparable between the groups. There were eight sedation failures (three of 15 in thiopental group and five of 14 in drug combination group, P = NS). Vital signs remained stable, no adverse reactions occurred, and no patient had decreased oxygen saturation to less than 95%. CONCLUSION: Rectal thiopental is superior to this drug combination for pediatric sedation because it can be administered painlessly, has a more rapid onset and offset of action, and is of equal safety and efficacy at the dosage studied.