Back to resultsPeri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine.
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Ketamine, Bupivacaine, tonsillectomy, analgesia
Eligibility Criteria
Inclusion criteria
- 3-20 years old patients
- elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.
Exclusion criteria
- allergy to bupivacaine or ketamine
- coagulopathy
- endocrine, neuropsychiatric or cardiopulmonary dysfunction
- increase intracranial pressure (ICP)
- psychiatric illness, history of seizure, patients under chronic analgesic treatment
- history of peritonsillar abscess, tonsillar malignancy.
Sites / Locations
- Sohag Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group K1 Ketamine
Group B1 Bupivacaine
Arm Description
pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area
pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area
Outcomes
Primary Outcome Measures
Postoperative pain
The pain will be assessed using modified Hannallah pain scale which includes blood pressure, movement, agitation and posture where zero is the least pain and 2 is the worest necessitating rescue analgesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341323
Brief Title
Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Official Title
Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2022 (Actual)
Primary Completion Date
July 2, 2022 (Actual)
Study Completion Date
July 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison between the analgesic effect of local infiltration of either Bupivacaine or ketamine in the peritonsillar area before the incision of tonsillectomy to achieve postoperative analgesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Ketamine, Bupivacaine, tonsillectomy, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group K1 Ketamine
Arm Type
Active Comparator
Arm Description
pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area
Arm Title
Group B1 Bupivacaine
Arm Type
Active Comparator
Arm Description
pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area
Intervention Type
Drug
Intervention Name(s)
Ketamine.
Intervention Description
Peritonsillar infiltration of ketamine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
peritonsillar infiltration of Bupivacaine
Primary Outcome Measure Information:
Title
Postoperative pain
Description
The pain will be assessed using modified Hannallah pain scale which includes blood pressure, movement, agitation and posture where zero is the least pain and 2 is the worest necessitating rescue analgesia
Time Frame
60 minutes postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
3-20 years old patients
elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.
Exclusion criteria
allergy to bupivacaine or ketamine
coagulopathy
endocrine, neuropsychiatric or cardiopulmonary dysfunction
increase intracranial pressure (ICP)
psychiatric illness, history of seizure, patients under chronic analgesic treatment
history of peritonsillar abscess, tonsillar malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahem Risk, Professor
Organizational Affiliation
Professor of ENT
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Osama Elshrief, Professor
Organizational Affiliation
Dean of Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Sohag Faculty of Medicine
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
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