Comparing NSAIDs Versus Steroid Injection in the Tonsil Area After Tonsillectomy to Manage Pain in Children Ages 4 to 10
Led by Ain Shams University · Updated on 2025-06-25
75
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of adding paracetamol to systemic non-steroidal anti-inflammatory drugs NSAIDs compared to adding dexamethasone directly into the tonsillar bed during surgery for controlling pain after tonsillectomy in children aged 4 to 10 years. This prospective randomized controlled study is conducted at Ain Shams University hospital and focuses on post-tonsillectomy pain management in children with chronic or recurrent tonsillitis or obstructive sleep apnea caused by tonsil issues.
Participants will be randomly assigned to one of three groups one receiving local steroid infiltration dexamethasone plus paracetamol, another receiving systemic NSAIDs plus paracetamol, and a control group receiving a combination of NSAIDs, steroids, and paracetamol as standard care. The study treatment occurs during and after tonsillectomy performed by cold dissection.
During the study, pain levels will be assessed at 6 hours, 24 hours, and 5 days after surgery. Additional pain medication needs, patient feedback, and any complications will be monitored over two weeks post-operation. Participants will have regular follow-up visits to evaluate pain control and record any side effects or complications related to the treatments.
CONDITIONS
Brief Title
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Research Team
A
Abdurrahman samir mohamed Mr, MBBS
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Indication for tonsillectomy including recurrent acute tonsillitis (7 episodes in one year or 5 per year for 2 years or 3 per year for 3 years)
Chronic tonsillitis and tonsil hypertrophy causing sleep apnea, swallowing difficulty, or speech interference
Tonsillectomy performed by cold dissection only
ASA classification 1 or 2 (normal health or mild systemic disease)
You will not qualify if you...
Age less than 4 or more than 10 years
Tonsillectomy indication other than chronic tonsillitis such as lymphoma
Current chronic steroid therapy
Hemoglobin level below 10 gm/dL
Acute upper respiratory infection or acute tonsillitis present
ASA classification 3 or 4 (severe systemic disease like uncontrolled diabetes, cardiac, liver, or kidney disease)
Regular use of analgesics within one week before surgery
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 weeks post surgery
Participants undergo tonsillectomy with either local steroid infiltration, systemic NSAIDs, or standard post-tonsillectomy medications to manage pain.
1 surgery visit and 3 follow-up visits within 5 days post-operatively
Follow-up
Duration - 2 weeks post-operatively
Participants are monitored for pain levels, additional medication needs, feedback, and complications after tonsillectomy.
1 follow-up visit at 2 weeks post-operatively
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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