The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
Launched by AIN SHAMS UNIVERSITY · Jun 15, 2025
Trial Information
Current as of July 04, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the best way to reduce pain after a tonsillectomy, which is surgery to remove the tonsils. Specifically, the study compares two pain relief methods: one uses common pain medicines called NSAIDs (like ibuprofen) combined with paracetamol (also known as acetaminophen), and the other adds a steroid medicine called dexamethasone directly into the area where the tonsils were removed, along with paracetamol. The goal is to find out which approach helps children feel less pain after their surgery.
Children between the ages of 4 and 10 who need a tonsillectomy because of frequent throat infections, long-lasting tonsillitis, or enlarged tonsils that cause sleep problems or trouble swallowing may be able to join the study. The surgery will be done using a specific technique called cold dissection. Kids with serious health issues, current infections, or those already taking steroids or pain medicines regularly won’t be eligible. If your child joins, they will receive one of the two pain control treatments after surgery, and the study team will monitor their pain levels to see which method works better. This trial is currently enrolling participants, and it aims to help improve comfort and recovery for children after tonsil removal.
Gender
ALL
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.
About Ain Shams University
Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported