Sevoflurane Induced Emergence Agitation

Ketamine

Brief 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.

Intervention / Treatment

  • Midazolam (DRUG)
    Group M
  • Alfentanil (DRUG)
    Group MA
  • Ketamine (DRUG)
    Group MK

Condition or Disease

  • Emergence Agitation

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 1 Year to 8 Years
    Enrollment: 78 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Feb 01, 2012
    Primary Completion: Aug 01, 2012 ACTUAL
    Completion Date: Aug 01, 2012 ACTUAL
    Study First Posted: Dec 27, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 26, 2013

    Sponsors / Collaborators

    Lead Sponsor: Yeditepe University Hospital
    Responsible Party: N/A

    Location

    Istanbul, Turkey

    Participant Groups

    • Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)

    • Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)

    • Midazolam 0.5mg/kg

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 8
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * 1- 8 years
    * American Society of Anesthesiologist (ASA) I-II,
    * Patients undergoing procedures below the umbilicus

    Exclusion Criteria:

    * cardiac diseases
    * pulmonary diseases
    * hepatic diseases
    * renal diseases
    * psychological or emotional disorders

    Primary Outcomes

    • Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

    Secondary Outcomes

    • Parental separation were evaluated with a 4- point scale in the preoperative period

    • The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period

    More Details

    NCT Number: NCT02022488
    Other IDs: 162
    Study URL: https://clinicaltrials.gov/study/NCT02022488
    Last updated: Sep 29, 2023