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Sevoflurane Induced Emergence Agitation

NCT02022488 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2013-12-30

No results posted yet for this study

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.

Conditions

  • Emergence Agitation

Interventions

DRUG

midazolam

Group M

DRUG

alfentanil

Group MA

DRUG

ketamine

Group MK

Sponsors & Collaborators

  • Yeditepe University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022488 on ClinicalTrials.gov