Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial
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


Options:
A: Inclusion Criteria:

* Complaint of acute pain of \< 7 days duration
* Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
* Radiologic evaluation is planned

Exclusion Criteria:

* Inability to confirm reliable means of phone followup.
* Past use of methadone
* Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
* History of an adverse reaction to any of the study medications
* Opioids taken in the past 24 hours
* Ibuprofen or acetaminophen taken in past 8 hours
* Pregnancy by either urine or serum HCG testing
* Breastfeeding per patient report
* History of peptic ulcer disease
* Report of any prior use of recreational narcotics
* Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
* Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
B: Inclusion Criteria:

* Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
* Isolated traumatic musculoskeletal pain
* Patients who agree to work and receive the approval
* VAS (visual analog scale) score\>5.

Exclusion Criteria:

* Patients with severe liver, kidney,pulmonary and cardiac heartfailure
* To be Pregnancy and breast-feeding
* Have received analgesics in the last 6hours
* Patients of childbearing age who are not using a birth control method.
* Patients with neurological deficits
* Patients with sciatica and back pain
* Patients with cardiac chest pain
* Patients with chronic pain
* Patients with pre-existing dexketoprofen and paracetamol-induced gastrointestinal bleeding and perforation
* Patients with reflected pain
* Patients with neoplastic pain
* Patients with an allergy trait (paracetamol and dexketoprofen)
* Illiterates and patients with vision problems
C: 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
D: Inclusion Criteria:

* Between the ages of 6 and 17 years
* Presenting to the ED with a musculoskeletal (MSK) trauma to either of the upper or lower limbs that is neither obviously deformed, nor neurovascularly compromised
* Self-reported pain score \>29 mm on a 0 to 100mm Visual Analogue Scale (VAS)
* Able to understand French or English.

Exclusion Criteria:

* Known allergy to morphine, ibuprofen, or artificial colouring
* MSK trauma that are suspected to be due to child abuse, as determined by the triage nurse
* Inability to self-report pain
* Chronic pain issues that require daily analgesic use
* NSAID or opioid analgesic use within three hours prior to presentation to triage (Exception of acetaminophen)
* Trauma to more than one limb (except fingers and toes)
* Known hepatic or renal disease/dysfunction
* Known bleeding disorder
* Neuro-cognitive disability that precludes patients from assenting and participating to the study.
* Known history of snoring consistently for the past 5 nights

Answer: C