Ketamine and Postoperative Analgesia in Children

Ketamine

Brief Summary

The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A

Condition or Disease

  • Postoperative Analgesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 6 Months to 6 Years
    Enrollment: 74 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized

    Masking

    Clinical Trial Dates

    Start date: Feb 01, 2004
    Primary Completion: Aug 31, 2020
    Completion Date: Aug 31, 2020
    Study First Posted: Sep 20, 2005 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 22, 2007

    Sponsors / Collaborators

    Lead Sponsor: Nantes University Hospital
    Responsible Party: N/A
    No responsible party listed

    Location

    Nantes, Pays de la Loire, France

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Children between 6 months to 6 years of age
    * American Society of Anesthesiologists (ASA) I or II
    * Undergoing elective surgery with intraoperative caudal analgesia

    Exclusion Criteria:

    * ASA III or IV
    * Contraindication to caudal anesthesia
    * Allergy to drugs used in the study
    * Failure in caudal puncture
    * Administration of morphine derivative

    Primary Outcomes
    • Area under the curve of pain scores (CHEOPS) measured every 2 hours during the first 24 hours after eyes open
    Secondary Outcomes
    • Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10 at the 24th hour
    • Number of painful episodes requiring additional boluses of nalbuphine
    • Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
    • Percentage of children with side effects related to injection of ketamine
    • Time to complete feeding
    • Percentage of children with nausea or vomiting

    More Details

    NCT Number: NCT00200564
    Other IDs: BRD/03/12-H
    Study URL: https://clinicaltrials.gov/study/NCT00200564
    Last updated: Sep 29, 2023