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

June 5, 2019 updated by: Hala Saad Abdel-Ghaffar, Assiut University

Topical Ketamine by Neubulization Method in Tonsillectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assiut Governorate
      • Assiut, Assiut Governorate, Egypt, Egypt,71571
        • Assiut University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesic consumption
Time Frame: 24 hours postoperative
The total amount of analgesics used in the first 24h postoperative in mg.
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: 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.

-

-

.
24 hours postoperative
Ketamine serum levels to exclude systemic absorption of topical ketamine.
Time Frame: 120 min after receiving Ketamine
the level of ketamine in the serum.
120 min after receiving Ketamine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssuitUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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