Paracetamol or NSAID's in minor musculoskeletal trauma.

Rationale:

Pain medication in patients with acute musculoskeletal syndromes is frequently
prescribed at the treating physician’s discretion and preferences. There is no convincing evidence about superiority of paracetamol or Non-Steroidal Anti-Inflammatory Drugs (NSAID’s) in these patients. Mainly NSAID’s can have detrimental adverse events. It is indicated to investigate which pharmacologic pain treatment is superior in managing pain in acute musculoskeletal syndromes.



Objective:

To compare analgesic efficacy of three different strategies of pain management; paracetamol or diclofenac only, or a combination, in adult patients with an acute musculoskeletal syndrome. Outcomes are evaluated in the acute phase and for three consecutive days after discharge. After one month a final evaluation will take place.



Study design:

Double-blind randomized controlled trial (RCT) with non-inferiority design.



Study population:

Adult patients, aged ≥ 18 years, presenting to the Emergency Department or in general practice with acute (<48 hours) blunt, traumatic limb injury.



Intervention:

Random allocation to: paracetamol, diclofenac or a combination of both. After discharge continuation with same study drugs as initially, during three days.



Main study parameters:

Pain, measured with Numerical Rating Scale (NRS) at rest and with limb movement in the acute phase before and after pain medication and after discharge using a pain diary for 3 days. Secondary outcomes are the occurrence of adverse effects, need for additional analgesia, patient satisfaction and measurement of health outcomes using a validated questionnaire.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients are treated with registered medication for pain. All patients who participate risk the occurrence of known side effects of the drugs allocated for, as described in the Summary of Product Characteristics (SPC). This risk is the same as in daily practice and probably smaller, as all individuals will receive proton pump inhibitors to protect patients from gastric damage from the NSAID’s. Strict exclusion criteria are maintained.

Paracetamol is not inferior to Diclofenac or the combination of Paracetamol + Diclofenac in treating pain in adult patients with acute traumatic musculoskeletal complaints.

Three phases:

1. At site of inclusion at 0, 30, 60 and 90 minutes;

2. Three consecutive days after discharge. Patients are contacted twice, once during these days and once right afterwards;

3. One month after inclusion, contact by telephone. End of study.

Patients are randomized into one of the following three pain management strategies:

1. Paracetamol 1000 mg initially and 1000 mg qid for three consecutive days after discharge;

2. Diclofenac 50 mg initially and 50 mg tds for three consecutive days after discharge;

3. Combination of Paracetamol 1000 mg and Diclofenac 50 mg initially and 1000 mg qid, 50 mg tds, respectively, for three consecutive days after discharge.

All study drugs are blinded. Besides these blinded drugs, all patients will take (non-blinded) Omeprazol 20 mg once daily during these three days (starting at site of presentation).