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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02720406
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
32
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous ketamine0.5mg/kg
  • Drug: Nebulized Ketamine 1mg/kg
  • Drug: Nebulized Ketamine 2mg/kg
  • Drug: saline placebo
 Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Topical Ketamine by Neubulization Method in Tonsillectomy
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intravenous ketamine0.5mg/kg

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

Drug: Intravenous ketamine0.5mg/kg
Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
Other Names:
  • Katalar

    		•
    Active Comparator: Nebulized ketamine 1mg/kg

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

    Drug: Nebulized Ketamine 1mg/kg
    Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
    Other Names:
  • Katalar

    		•
    Active Comparator: Nebulized ketamine 2mg/kg

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

    Drug: Nebulized Ketamine 2mg/kg
    Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
    Other Names:
  • Katalar

    		•
    Placebo Comparator: control group

    control group received placebo nebulization

    Drug: saline placebo
    Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative analgesic consumption [24 hours postoperative]

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

    Secondary Outcome Measures

    1. Postoperative pain scores [24 hours postoperative]

      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. - - .

    2. Ketamine serum levels to exclude systemic absorption of topical ketamine. [120 min after receiving Ketamine]

      the level of ketamine in the serum.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospitals Assiut Assiut Governorate Egypt Egypt,71571

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hala S Abdel-Ghaffar, MD, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, MD, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02720406
    Other Study ID Numbers:
    • AssuitUniversity
    First Posted:
    Mar 25, 2016
    Last Update Posted:
    Jun 7, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ketamine

    Study Results

    No Results Posted as of Jun 7, 2019