Oral NSAIDs plus paracetamol versus local dexamethasone infiltration for post-tonsillectomy pain in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized controlled trial at Ain Shams University Hospital comparing two pain-management strategies after cold-dissection tonsillectomy in children aged 4–10. Participants will be randomized to receive either systemic NSAIDs plus paracetamol or local infiltration of dexamethasone into the tonsillar bed alongside paracetamol. Recruitment occurs from outpatient ENT clinics and inpatient services with follow-up during the postoperative period to measure pain and recovery over a six-month study period. Eligible patients are ASA I–II, have hemoglobin ≥10 g/dL, and do not have acute upper respiratory infection or chronic steroid therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ainshams university hospitals
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Abdurrahman samir mohamed Mr, MBBS
• Email: samirabdelrahman114@gmail.com
• Phone: 01069466215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.