Comparison between combination of intravenous ibuprofen and intravenous paracetamol (Acetaminophen) versus combination of diclofenac suppository and intravenous paracetamol for perioperative pain control in Children Undergoing tonsillectomy with or without adenoidectomy.

Comparison between combination of intravenous ibuprofen and intravenous paracetamol (Acetaminophen) versus combination of diclofenac suppository and intravenous paracetamol for perioperative pain control in Children Undergoing tonsillectomy with or without adenoidectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202411717431200

Enrollment

Registered

2024-11-19

Start date

2023-01-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Ear, Nose and Throat Surgery Paediatrics Anaesthesia

Interventions

Ibuprofen

Diclofenac suppository

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Participants were children aged 1year to 7 years 2.classified as American Society of Anaesthesiologists physical status I or II 3.scheduled for tonsillectomy operation with or without adenoidectomy.

Exclusion criteria

Exclusion criteria: 1.Past medical history of cardiopulmonary, renal, or hepatic dysfunction, or asthma, gastrointestinal bleeding, coagulation disorder. 2. hypersensitivity to either NSAIDs or paracetamol.

Design outcomes

Primary

Measure	Time frame
FLACC score at 10 minutes after discharge to PACU	—

Secondary

Measure	Time frame
1. FLACC score at discharge from PACU 2. PPPM scores at 4, 12, and 24 hours after the operation. 3. Time to first analgesic requirement (defined as time from exudation to time of first analgesic requirement) he 4. pain medicine requirements 24hour postoperative period 5. the number of children who received rescue pethidine in the PACU. 6. The incidence of postoperative nausea and vomiting (PONV). 7. adverse events (hypotension (Low SBP = <70 + 2(age in years), bradycardia less than 60 beat/min, and drug allergic reaction) 8. Incidence of post-operative bleeding requiring return to operative room in the first 24 hours.	—

Measure

Time frame

1. FLACC score at discharge from PACU 2. PPPM scores at 4, 12, and 24 hours after the operation. 3. Time to first analgesic requirement (defined as time from exudation to time of first analgesic requirement) he 4. pain medicine requirements 24hour postoperative period 5. the number of children who received rescue pethidine in the PACU. 6. The incidence of postoperative nausea and vomiting (PONV). 7. adverse events (hypotension (Low SBP = <70 + 2(age in years), bradycardia less than 60 beat/min, and drug allergic reaction) 8. Incidence of post-operative bleeding requiring return to operative room in the first 24 hours.

—

Countries

Egypt

Contacts

Public ContactKareem Nagy

Lecturer

morotoxic88@gmail.com+201001223232

Outcome results

None listed

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