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Paracetamol vs Ketorolac for Post-operative Pain
NCT05523102Phase 4
Key facts
- Status
- Completed
- Start
- Mar 2022
- Primary completion
- Jul 2022
- Countries
- 1
- Sponsor
- Universitas Indonesia
- Modality
- Small Molecules
- Drugs
- acetaminophen
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, single-blind trial of acetaminophen in postoperative pain (2 arms), sponsored by Universitas Indonesia. Primary endpoint: revised Face, Legs, Activity, Cry, Consolability scale at 48 hours. Started Mar 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Paracetamol Arm
Paracetamol 15mg/kg 6 hourly + Nalbuphine SOS
Ketorolac Arm
Ketorolac 0.5mg/kg 8 hourly + Nalbuphine SOS
03
Who it enrols
Postoperative patients admitted to Neurosurgery HCU or PICU. Excludes patients with liver dysfunction, renal failure, allergy to study drugs, or opioid administration within 24 hours before surgery.
04
Endpoints
Primary
revised Face, Legs, Activity, Cry, Consolability scale
Secondary
Total dose of opioid administered
Adverse effects
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