Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

July 17, 2022 updated by: Mohamed Abdallah Abozaid, Sohag University

Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

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
      • Sohag, Egypt
        • Sohag Faculty of Medicine

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

3 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group K1 Ketamine
pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area
Drug: Ketamine.
Peritonsillar infiltration of ketamine
Active Comparator: Group B1 Bupivacaine
pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area
Drug: Bupivacaine
peritonsillar infiltration of Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 60 minutes postoperatively
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
60 minutes postoperatively

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Study Director: Ibrahem Risk, Professor, Professor of ENT
  • Study Chair: Osama Elshrief, Professor, Dean of Faculty of Medicine

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 2, 2022

Primary Completion (Actual)

July 2, 2022

Study Completion (Actual)

July 2, 2022

Study Registration Dates

First Submitted

April 3, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh_Med_22_02_07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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