RecruitingNot ApplicableNCT07035314

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: A Prospective Randomized Controlled Study.


Sponsor

Ain Shams University

Enrollment

75 participants

Start Date

Mar 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 10 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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.

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Interventions

PROCEDUREDexamethasone

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

DRUGNSAIDs

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

DRUGControl (Standard treatment)

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


Locations(1)

Ainshams university hospitals

Cairo, Egypt

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NCT07035314


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