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Comparing Pain Relief After Tonsil and Adenoid Surgery in Children: Diclofenac vs. Acetaminophen Suppositories

Comparative study of post-operative analgesia using Diclofenac sodium suppository vs Acetaminofen suppository in children undergoing Adenotonsillectomy - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086328
Enrollment
100
Registered
2025-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Diclofenac sodium suppository: Dose 2mg/kg Inserted rectally post intubation VAS score post-operatively at 10,20 min then hourly till the patient is given rescue analgesia Control Inter

Sponsors

Dr Mandava Bharath Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I or II fit patients. 2. Patients aged between 5 and 12 years of age. 3. Patients undergoing elective adenotonsillectomy pediatric surgery. 4. Written informed consent from the concerned patient guardian

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to participate in the study. 2. Patients with ASA grade III and above physical status. 3. Patients who are posted for emergency procedures. 4. Patients with known allergy to the study drugs. 5. Patients who have psychiatric, coagulopathies, neurological, neuromuscular, or cardiovascular disease or impairment of hepatic or renal function. 6. Patients with inflammatory conditions of rectum and anal canal.

Design outcomes

Primary

MeasureTime frame
To assess the Visual Analogue Scale(VAS) score post operativelyTimepoint: At 10 and 20 mins, and then hourly, till patients received rescue analgesic.

Secondary

MeasureTime frame
To assess the Visual Analogue Scale(VAS) score post operatively in children undergoing adenotonsillectomyTimepoint: Duration of analgesia will be assessed post surgery once the effects of the suppository decrease & time to rescue to analgesia will be assessed 2 hours after surgery & hourly until intervention is required

Countries

India

Contacts

Public ContactDr Sonal Khatavkar

DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE

ksonal0711@gmail.com9820434472

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026