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Clinical Trials in Egypt / NCT07035314
Recruiting Not applicable

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

NCT07035314 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ain Shams University
Phase
Not applicable
Started
2025-03-08
Last updated
2025-06-25

Condition(s) studied

Tonsillitis ChronicTonsillitis RecurrentOSA - Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

DexamethasoneNSAIDs →Control (Standard treatment)

Dexamethasone: 1- First group: will receive local infiltration of steroids (dexamethasone) in tonsillar bed and paracetamol.

NSAIDs: 2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the analgesic and anti-inflammatory dosage and paracetamol.

Control (Standard treatment): 3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard post tonsillectomy medications in our department.

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
10 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Ainshams university hospitals Cairo Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035314 on ClinicalTrials.gov ↗ ← All trials in Egypt