Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

• Sponsor: Sohag University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05341323
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 26.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: Ketamine.; Drug: Bupivacaine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison Between Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
• Actual Study Start Date: Apr 2, 2022
• Actual Primary Completion Date: Jul 2, 2022
• Actual Study Completion Date: Jul 2, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Postoperative pain [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag Faculty of Medicine	Sohag		Egypt

Sponsors and Collaborators

• Sohag University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Abdallah Abozaid, Resident doctor at otorhinolaryngiology, head and neck surgery department, Sohag University
• ClinicalTrials.gov Identifier: NCT05341323
• Other Study ID Numbers: Soh_Med_22_02_07
• First Posted: Apr 22, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Abdallah Abozaid, Resident doctor at otorhinolaryngiology, head and neck surgery department, Sohag University: Ketamine; Bupivacaine; tonsillectomy; analgesia
• Additional relevant MeSH terms: Pain, Postoperative; Ketamine; Bupivacaine

Study Results

No Results Posted as of Jul 19, 2022