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

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.

This test will see if children aged 4–10 have less pain after tonsillectomy when given oral NSAIDs with paracetamol versus when dexamethasone is injected into the tonsil beds.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 4 Years to 10 Years
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07035314 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 4–10 undergoing cold-dissection tonsillectomy for recurrent or chronic tonsillitis or sleep-disordered breathing who are ASA class I–II and free of acute infection or chronic steroid use are the ideal candidates.

Not a fit: Children under 4 or over 10, those with severe systemic disease (ASA III–IV), active upper respiratory infection, low hemoglobin, chronic steroid therapy, or alternative surgical indications such as suspected lymphoma are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could provide clearer guidance to reduce post-tonsillectomy pain in children, improving comfort and recovery while potentially limiting systemic side effects.

How similar studies have performed: Previous studies show that both perioperative systemic NSAIDs and corticosteroids can reduce post-tonsillectomy pain and related symptoms, but direct head-to-head comparisons of local steroid infiltration versus systemic NSAIDs plus paracetamol in this pediatric group are limited.

Eligibility criteria

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 this trial is running

Cairo

• Ainshams university hospitals — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Abdurrahman samir mohamed Mr, MBBS

Conditions: Tonsillitis Chronic, Tonsillitis Recurrent, OSA - Obstructive Sleep Apnea, tonsillitis, tonsillectomy, post tonsillectomy pain, Dexamethasone infiltration in tonsillar bed, NSAIDs