Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

NCT05341323 | Completed Phase 4

• 1 other identifier: Soh_Med_22_02_07
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain

Keywords

Ketamine; Bupivacaine; tonsillectomy; analgesia

Outcome Measures

Primary Outcomes (1)

• 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

  60 minutes postoperatively

Study Arms (2)

Group K1 Ketamine

ACTIVE COMPARATOR

pre-incisional submucosal infiltration of ketamine .5 mg/kg in the Peritonsillar area

Drug: Ketamine.

Group B1 Bupivacaine

ACTIVE COMPARATOR

pre-incisional submucosal infiltration of Bupivacaine .25 % in the Peritonsillar area

Drug: Bupivacaine

Interventions

Ketamine. DRUG

Peritonsillar infiltration of ketamine

Group K1 Ketamine

Bupivacaine DRUG

peritonsillar infiltration of Bupivacaine

Group B1 Bupivacaine

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old patients
• elective tonsillectomy or adenotonsillectomy with or without ventilation tube application.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Ibrahem Risk, Professor

  Professor of ENT

  STUDY DIRECTOR

• Osama Elshrief, Professor

  Dean of Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at otorhinolaryngiology, head and neck surgery department

Study Record Dates

• First Submitted: April 3, 2022
• First Posted: April 22, 2022
• Study Start: April 2, 2022
• Primary Completion: July 2, 2022
• Study Completion: July 2, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

EG (1)