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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Intravenous ketamine0.5mg/kg
Nebulized Ketamine 1mg/kg
Nebulized Ketamine 2mg/kg
saline placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Intravenous ketamine0.5mg/kg

Nebulized ketamine 1mg/kg

Nebulized ketamine 2mg/kg

control group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain scores
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. - - .
Ketamine serum levels to exclude systemic absorption of topical ketamine.
the level of ketamine in the serum.

Full Information

First Posted
March 22, 2016
Last Updated
June 5, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02720406
Brief Title
Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.
Official Title
Topical Ketamine by Neubulization Method in Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous ketamine0.5mg/kg
Arm Type
Active Comparator
Arm Description
intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery.
Arm Title
Nebulized ketamine 1mg/kg
Arm Type
Active Comparator
Arm Description
nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia.
Arm Title
Nebulized ketamine 2mg/kg
Arm Type
Active Comparator
Arm Description
nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
control group received placebo nebulization
Intervention Type
Drug
Intervention Name(s)
Intravenous ketamine0.5mg/kg
Other Intervention Name(s)
Katalar
Intervention Description
Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
Intervention Type
Drug
Intervention Name(s)
Nebulized Ketamine 1mg/kg
Other Intervention Name(s)
Katalar
Intervention Description
Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
Intervention Type
Drug
Intervention Name(s)
Nebulized Ketamine 2mg/kg
Other Intervention Name(s)
Katalar
Intervention Description
Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
Intervention Type
Drug
Intervention Name(s)
saline placebo
Other Intervention Name(s)
Saline
Intervention Description
Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
Primary Outcome Measure Information:
Title
Postoperative analgesic consumption
Description
The total amount of analgesics used in the first 24h postoperative in mg.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
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. - - .
Time Frame
24 hours postoperative
Title
Ketamine serum levels to exclude systemic absorption of topical ketamine.
Description
the level of ketamine in the serum.
Time Frame
120 min after receiving Ketamine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdel-Ghaffar, MD
Organizational Affiliation
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
Egypt,71571
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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