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

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

Recruiting
4-10 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Tonsillitis Chronic
    Tonsillitis Recurrent
    OSA - Obstructive Sleep Apnea

NCT07035314

Ain Shams University

3 July 2025

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