Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.

Ketamine

Brief Summary

The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations

Intervention / Treatment

  • Intravenous ketamine0.5mg/kg (DRUG)
    Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
  • Nebulized Ketamine 1mg/kg (DRUG)
    Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
  • Nebulized Ketamine 2mg/kg (DRUG)
    Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
  • saline placebo (DRUG)
    Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 7 Years to 12 Years
    Enrollment: 100 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2016 ACTUAL
    Primary Completion: Dec 01, 2018 ACTUAL
    Completion Date: Dec 01, 2018 ACTUAL
    Study First Posted: Mar 25, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 05, 2019

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.

    Participant Groups

    • intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery.

    • nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia.

    • nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia.

    • control group received placebo nebulization

    Eligibility Criteria

    Sex: All
    Minimum Age: 7
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study

    Exclusion Criteria:

    * patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.

    Primary Outcomes

    • The total amount of analgesics used in the first 24h postoperative in mg.

    Secondary Outcomes

    • Pain intensity will be assessed postoperatively by using the Verbal Rating scale (VRS) (0 =no pain, 1 =mild pain, 2 =moderate pain, 3 =severe pain, and lastly 4 =excruciating pain). VRS assessments were performed at rest in the following time points; at arrival to PACU, 30 min, 1, 2, 3, 4, 5, 6, 12, and 24 h postoperative. - - .

    • the level of ketamine in the serum.

    More Details

    NCT Number: NCT02720406
    Other IDs: AssuitUniversity
    Study URL: https://clinicaltrials.gov/study/NCT02720406
    Last updated: Sep 29, 2023