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Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial

Cost-effectiveness analysis of oral paracetamol and ibuprofen for treating pain after soft tissue limb injuries: double-blind, randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94738550
Enrollment
783
Registered
2007-10-19
Start date
2005-01-01
Completion date
Unknown
Last updated
2021-07-26

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

Conditions

Soft Tissue Injuries Injury, Occupational Diseases, Poisoning Soft Tissue Injuries

Interventions

Arm 1: Paracetamol 1 g four times daily (qid) and ibuprofen placebo equivalent to 400 mg three times daily (tid) Arm 2: Paracetamol placebo equivalent to 1 g qid and ibuprofen 400 mg t

Sponsors

Chinese University of Hong Kong (Hong Kong)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients greater than 16 years presenting to the Emergency Department (ED) with isolated soft tissue injury without significant fracture between 9 am to 5 pm, Monday to Friday.

Exclusion criteria

Exclusion criteria: Patients will be excluded if there is: 1. A history of peptic ulceration or haemorrhage 2. Recent anticoagulation 3. Pregnancy 4. Adverse reaction to paracetamol or ibuprofen 5. Renal or cardiac failure 6. Hepatic problems 7. Rectal bleeding 8. Chronic Non-Steriodal Anti-Inflammatory Drug (NSAID) consumption 9. Asthma 10. Chronic obstructive pulmonary disease 11. Chronic pain syndromes 12. Prior treatment with analgesia for the same injury Patients will also be excluded if they have a physical, visual or cognitive impairment making use of the visual analogue scale unreliable.

Design outcomes

Primary

MeasureTime frame
Analgesic efficacy both at rest and with movement at 72 hours.

Secondary

MeasureTime frame
1. Presence, frequency and duration of adverse effects at 30 days 2. Cost-effectiveness analysis at 30 days 3. Patient satisfaction with analgesia at 30 days

Countries

Hong Kong

Outcome results

None listed

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