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
About this trial
This is an interventional treatment trial for Postoperative Pain
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.
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
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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