drugset / Trial / NCT02022488

Sevoflurane Induced Emergence Agitation

NCT02022488

Phase 4 Completed 78 enrolled Yeditepe University Hospital
RandomizedParallel-groupTriple-blindPrevention

Summary

Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.

Timeline

Start
2012-02
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alfentanil Other / unclassified 10 ug/kg Oral
Comparator Ketamine Small molecule 2 mg/kg Intranasal
Comparator Midazolam Small molecule 0.5 mg/kg Oral

Indications

No indication recorded.