Tags

Type your tag names separated by a space and hit enter

Does midazolam alter the clinical effects of intravenous ketamine sedation in children? A double-blind, randomized, controlled, emergency department trial.
Ann Emerg Med. 2000 Dec; 36(6):579-88.AE

Abstract

STUDY OBJECTIVE

This study was conducted to investigate the frequency and severity of adverse effects, specifically emergence phenomena, experienced by patients receiving intravenous ketamine with or without midazolam for sedation in a pediatric emergency department.

METHODS

Patients aged 4.5 months to 16 years receiving ketamine sedation were prospectively enrolled in a double-blind, randomized, controlled study at a university-affiliated children's hospital-pediatric ED. All patients received ketamine (1 mg/kg) and glycopyrrolate (5 microgram/kg) intravenously. Patients were randomly assigned to receive midazolam (0.1 mg/kg) intravenously or no midazolam. Total time of sedation, sedation efficacy, and adverse effects were recorded. Adverse effects were compared between patients receiving ketamine versus those who received ketamine and midazolam. Additional comparisons were made based on age and number of ketamine doses administered.

RESULTS

Two hundred sixty-six patients were studied; 129 received ketamine and 137 patients received ketamine and midazolam. Time of sedation and efficacy of sedation were equivalent between groups. Overall, adverse effects with ketamine sedation included respiratory events (12 [4.5%]), vomiting (50 [18.7%]), emergence phenomena in the pediatric ED (71 [26.7%]), and emergence phenomena at home (60 [22.4%]). Significant emergence phenomena in the pediatric ED (ie, nightmares, hallucinations, and severe agitation) occurred in 7.1% of the ketamine group and in 6.2% of the ketamine-midazolam group, a rate difference of 0.8 (95% confidence interval [CI] -5.3 to 7.0). The addition of midazolam led to an increased incidence of oxygen desaturation events (ketamine 1.6% versus ketamine-midazolam 7.3%; rate difference -5.7, 95% CI -10.6 to -0.9) but a decreased incidence of vomiting (ketamine 19.4%, ketamine-midazolam 9.6%, rate difference 9.8, 95% CI 1.4 to 18.2). The incidence of emergence phenomena and significant emergence phenomena was not affected by the addition of midazolam. However, the addition of midazolam was associated with more agitation in the pediatric ED in children 10 years or older (ketamine 5.7% versus ketamine-midazolam 35.7%; rate difference -30.0, 95% CI -10.7 to -49.3). Age breakdown further showed 6.3% (95% CI 0.9 to 11.6) more episodes of oxygen desaturation in the ketamine-midazolam group in children younger than 10 years, and 12.1% (95% CI 1.5 to 22.6) more vomiting episodes in the ketamine group in children younger than 10 years.

CONCLUSION

Ketamine and combined ketamine and midazolam provided equally effective sedation. The addition of midazolam did not alter the incidence of emergence phenomena. Vomiting occurred more frequently in the ketamine only group, whereas oxygen desaturation occurred more frequently in the ketamine-midazolam group. These findings were more pronounced in patients younger than 10 years. Parental and physician satisfaction remained high for all patients receiving intravenous ketamine sedation.

Authors+Show Affiliations

Department of Pediatrics, Section of Emergency Medicine, University of Colorado Health Sciences Center/The Children's Hospital, Denver, CO, USA. Wathen.Joseph@tchden.orgNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

11097698

Citation

Wathen, J E., et al. "Does Midazolam Alter the Clinical Effects of Intravenous Ketamine Sedation in Children? a Double-blind, Randomized, Controlled, Emergency Department Trial." Annals of Emergency Medicine, vol. 36, no. 6, 2000, pp. 579-88.
Wathen JE, Roback MG, Mackenzie T, et al. Does midazolam alter the clinical effects of intravenous ketamine sedation in children? A double-blind, randomized, controlled, emergency department trial. Ann Emerg Med. 2000;36(6):579-88.
Wathen, J. E., Roback, M. G., Mackenzie, T., & Bothner, J. P. (2000). Does midazolam alter the clinical effects of intravenous ketamine sedation in children? A double-blind, randomized, controlled, emergency department trial. Annals of Emergency Medicine, 36(6), 579-88.
Wathen JE, et al. Does Midazolam Alter the Clinical Effects of Intravenous Ketamine Sedation in Children? a Double-blind, Randomized, Controlled, Emergency Department Trial. Ann Emerg Med. 2000;36(6):579-88. PubMed PMID: 11097698.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Does midazolam alter the clinical effects of intravenous ketamine sedation in children? A double-blind, randomized, controlled, emergency department trial. AU - Wathen,J E, AU - Roback,M G, AU - Mackenzie,T, AU - Bothner,J P, PY - 2000/11/30/pubmed PY - 2001/2/28/medline PY - 2000/11/30/entrez SP - 579 EP - 88 JF - Annals of emergency medicine JO - Ann Emerg Med VL - 36 IS - 6 N2 - STUDY OBJECTIVE: This study was conducted to investigate the frequency and severity of adverse effects, specifically emergence phenomena, experienced by patients receiving intravenous ketamine with or without midazolam for sedation in a pediatric emergency department. METHODS: Patients aged 4.5 months to 16 years receiving ketamine sedation were prospectively enrolled in a double-blind, randomized, controlled study at a university-affiliated children's hospital-pediatric ED. All patients received ketamine (1 mg/kg) and glycopyrrolate (5 microgram/kg) intravenously. Patients were randomly assigned to receive midazolam (0.1 mg/kg) intravenously or no midazolam. Total time of sedation, sedation efficacy, and adverse effects were recorded. Adverse effects were compared between patients receiving ketamine versus those who received ketamine and midazolam. Additional comparisons were made based on age and number of ketamine doses administered. RESULTS: Two hundred sixty-six patients were studied; 129 received ketamine and 137 patients received ketamine and midazolam. Time of sedation and efficacy of sedation were equivalent between groups. Overall, adverse effects with ketamine sedation included respiratory events (12 [4.5%]), vomiting (50 [18.7%]), emergence phenomena in the pediatric ED (71 [26.7%]), and emergence phenomena at home (60 [22.4%]). Significant emergence phenomena in the pediatric ED (ie, nightmares, hallucinations, and severe agitation) occurred in 7.1% of the ketamine group and in 6.2% of the ketamine-midazolam group, a rate difference of 0.8 (95% confidence interval [CI] -5.3 to 7.0). The addition of midazolam led to an increased incidence of oxygen desaturation events (ketamine 1.6% versus ketamine-midazolam 7.3%; rate difference -5.7, 95% CI -10.6 to -0.9) but a decreased incidence of vomiting (ketamine 19.4%, ketamine-midazolam 9.6%, rate difference 9.8, 95% CI 1.4 to 18.2). The incidence of emergence phenomena and significant emergence phenomena was not affected by the addition of midazolam. However, the addition of midazolam was associated with more agitation in the pediatric ED in children 10 years or older (ketamine 5.7% versus ketamine-midazolam 35.7%; rate difference -30.0, 95% CI -10.7 to -49.3). Age breakdown further showed 6.3% (95% CI 0.9 to 11.6) more episodes of oxygen desaturation in the ketamine-midazolam group in children younger than 10 years, and 12.1% (95% CI 1.5 to 22.6) more vomiting episodes in the ketamine group in children younger than 10 years. CONCLUSION: Ketamine and combined ketamine and midazolam provided equally effective sedation. The addition of midazolam did not alter the incidence of emergence phenomena. Vomiting occurred more frequently in the ketamine only group, whereas oxygen desaturation occurred more frequently in the ketamine-midazolam group. These findings were more pronounced in patients younger than 10 years. Parental and physician satisfaction remained high for all patients receiving intravenous ketamine sedation. SN - 0196-0644 UR - https://www.unboundmedicine.com/medline/citation/11097698/Does_midazolam_alter_the_clinical_effects_of_intravenous_ketamine_sedation_in_children_A_double_blind_randomized_controlled_emergency_department_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0196-0644(00)47787-5 DB - PRIME DP - Unbound Medicine ER -