Actively Recruiting
Led by Ain Shams University · Updated on 2025-06-25
75
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Ainshams university hospitals
Cairo, Egypt
Actively Recruiting
A
Abdurrahman samir mohamed Mr, MBBS
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Ravi Ranjan Verma, Rajan Sriraman, Samir Kumar Rana...
https://pubmed.ncbi.nlm.nih.gov/24012792