Paracetamol or NSAID’s in acute disorders of the musculoskeletal tract

Phase 1

Conditions: acute musculoskeletal syndromes
MedDRA version: 17.1Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 100000004865
MedDRA version: 17.1Level: LLTClassification code 10033762Term: ParacetamolSystem Organ Class: 100000004848
MedDRA version: 17.1Level: HLGTClassification code 10005942Term: Bone and joint injuriesSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 17.1Level: HLTClassification code 10028288Term: Muscle, tendon and ligament injuriesSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-000381-11-NL

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- adult (18 years and older) patients
- presenting to the emergency department of the Academic Medical Centre (AMC) or to a general practice in Amsterdam South-East (Gezondheidscentrum Gein)
- with traumatic musculoskeletal complaints: isolated, non-penetrating injury of a limb, without a fracture
- within 48 hours

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 547
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 547

Exclusion Criteria

- previous treatment with analgesia for the same injury
- self inflicted injury (auto-mutilation”)
- presence of wound, joint dislocation, fracture or more then one injury
- daily use of paracetamol and/or NSAID’s and/or other analgesia within two weeks before presentation
- patients with chronic pain
- previous adverse reaction or known allergy to paracetamol, NSAID’s or omeprazol
- pregnancy
- previous gastro-intestinal hemorrhage or perforation after NSAID use
- active or recurrent peptic ulceration or peptic bleeding (2 or more evident episodes)
- previous exacerbation of asthma after use of NSAID’s or acetylsalicylic acid
- severe cardiac failure
- liver cirrhosis
- severe renal insufficiency (eGFR<30mL/min)
- bone marrow depression or blood dyscrasia (active or in past medical history)
- combined use of angiotensin converting enzyme inhibitors (or angiotensin receptor blockers) AND diuretics
- physical, visual or cognitive impairment or non-Dutch language speaking (unable to use NRS, pain diary or EQ5D questionnaire)