The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.

Not Applicable

Recruiting

• Conditions: Tonsillitis Chronic; Tonsillitis Recurrent; OSA - Obstructive Sleep Apnea
• Interventions: Procedure: Dexamethasone; Drug: NSAIDs; Drug: Control (Standard treatment)

• Registration Number: NCT07035314
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is to compare the efficacy of adding paracetamol to systemic non-steroidal anti-inflammatory drugs (NSAIDs) versus adding dexamethasone as local infiltration to paracetamol on post tonsillectomy pain control.

Detailed Description

A Prospective Randomized Controlled study. The study will be conducted at Ain Shams University hospital, Otolaryngology Department. Study period is 6 months from approval of the protocol. Study Participants will be recruited from outpatient ENT clinic, and ENT department inpatients.

Study Timeline

• Study Start: 2025-03-08
• Study First Submitted: 2025-04-04
• Status Verified: 2025-05
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Age: Between 4-10 years.

• Indications of tonsillectomy such as:

  • Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years.
  • Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, interference in speech.

• Tonsillectomy by cold dissection only.

• American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild systematic disease).

Exclusion Criteria

• Patients with age less than 4 and more than 10 years.
• Indications of tonsillectomy other than chronic tonsillitis such as lymphoma.
• Patients on chronic steroid therapy
• Hemoglobin level less than 10 gm/dL
• Presence of acute infection in the upper respiratory tract, acute tonsillitis
• American Society of Anesthesiologists (ASA) classification ASA 3,4 (Severe systematic disease such as uncontrolled Diabetes, cardiac disease, liver or kidney disease, life threating medical conditions)
• Regular use of analgesics within a week of surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par	Dexamethasone	1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and par
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and ant	NSAIDs	2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill	Control (Standard treatment)	3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsill

Primary Outcome Measures

Name	Time	Method
post tonsillectomy pain	DAY 0 6h, 24h post-operatively and DAY 5 post-operatively	The primary endpoints that will be used is resting pain scores using virtual analogue scale; VAS score (0: no pain-10: worst pain) at DAY 0 after 6h, 24h and DAY 5 post-operatively. Where pain score will be measured at multiple points during the outcome intervals, the pain scores at the time closest to six and 24h will be used.

Secondary Outcome Measures

Name	Time	Method
Additional pain medication needed	2 weeks post operatively	The percentage of the patients in group 1 and 2 that will need extra analgesia
Pt feedback after tonsillectomy	2 weeks post operatively	Patient satisfaction and return to normal activity.
Complications	2 weeks post operatively	Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy bleeding.

Trial Locations

Locations (1)

Ainshams university hospitals; 🇪🇬 Cairo, Egypt