EUCTR2013-000381-11-NLActive, not recruitingPhase 1
Paracetamol or NSAID's in acute musculoskeletal syndromes - The PanAM Study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Academisch Medisch Centrum
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
Investigators
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