Clinical trial NCT00528658: Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Official title: Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Injuries
Keywords: Soft Tissue Injuries
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Academy of Medicine
First posted: 2007-09-12
Enrollment: 782
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but throughout the world. There are no large-scale (n\>100), prospective, randomised studies comparing paracetamol with ibuprofen in the management of acute soft tissue injury.

As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness. Previous comparative studies on NSAIDS have been done in this unit and have suggested equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were modest.

Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in pain control for acute soft tissue injuries in an ED setting

Design: Prospective, double-blind, randomised controlled trial with three arms: oral paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in combination

Participants: 783 subjects having sustained isolated soft tissue limb injury without significant fracture presenting to the ED of Prince of Wales Hospital

Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective of the healthcare provider


Eligibility criteria: Inclusion Criteria:

* All patients \>16 years presenting to the ED with isolated soft tissue injury without significant fracture
* between 9am to 5pm, Monday to Friday,

Exclusion Criteria:

* History of :

  * peptic ulceration or hemorrhage
  * recent anticoagulation
  * pregnancy
  * adverse reaction to paracetamol or ibuprofen
  * renal or cardiac failure
  * hepatic problems
  * rectal bleeding
  * chronic NSAID consumption
  * asthma
  * chronic obstructive pulmonary disease
  * chronic pain syndromes
  * prior treatment with analgesia for the same injury
  * physical, visual or cognitive impairment making use of the visual analogue scale unreliable

Primary outcomes:
measure: analgesic efficacy both at rest and with movement
timeFrame: 72 hours
Secondary outcomes:
measure: presence, frequency and duration of adverse effects; cost-effectiveness analysis; patient satisfaction with analgesia
timeFrame: 30 days
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
state: NT
Study officials:
affiliation: Chinese University of Hong Kong
name: Colin A Graham
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hung KKC, Graham CA, Lo RSL, Leung YK, Leung LY, Man SY, Woo WK, Cattermole GN, Rainer TH. Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial. PLoS One. 2018 Feb 6;13(2):e0192043. doi: 10.1371/journal.pone.0192043. eCollection 2018.