Analgesia Acute musculoskeletal syndromes Minor injuries Analgesie Contusies Distorsies
Conditions
Interventions
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 b
Sponsors
Academic Medical Centre (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged ≥ 18 years; 2. Non-penetrating limb injury, meaning a painful, acute strain, sprain or contusion of an extremity; 3. Trauma occurred within 48 hours before presentation; 4. All patients with pain (mild, moderate and severe) scored with NRS (severity is no inclusion criterium).
Exclusion criteria
Exclusion criteria: 1. Previous treatment with analgesia for the same injury; 2. Self inflicted injury (“auto-mutilation”); 3. Presence of wound, joint dislocation, fracture or more then one injury; 4. Daily use of paracetamol and/or NSAID’s and/or other analgesia within two weeks before presentation; 5. Patients with chronic pain; 6. Previous adverse reaction or known allergy to paracetamol, NSAID’s or omeprazol; 7. Pregnancy; 8. Previous gastro-intestinal hemorrhage or perforation after NSAID use; 9. Active or recurrent peptic ulceration or peptic bleeding (2 or more evident episodes); 10. Previous exacerbation of asthma after use of NSAID’s or acetylsalicylic acid; 11. Severe cardiac failure; 12. Liver cirrhosis; 13. Severe renal insufficiency (eGFR<30mL/min); 14. Bone marrow depression or blood dyscrasia (active or in past medical history); 15. Combined use of angiotensin converting enzyme inhibitors (or angiotensin receptor blockers) AND diuretics; 16. Physical, visual or cognitive impairment or non-Dutch language speaking (unable to use NRS, pain diary or EQ5D questionnaire).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in decrease in NRS at baseline and at 90 minutes after study drug administration. Pain will be measured in rest and with active / passive movement of the extremity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NRS pain measurement in rest and wth active / passive movement of the extremity at 30 and 60 minutes at site of inclusion; 2. NRS pain measurement after discharge from the emergency department or the general practice by means of a pain diary. Pain is measured tds in rest and with usual daily activity (walking, bathing, going to the toilet); 3. Proportional changes in pain; 33% decrease and NNT to achieve 33% decrease in NRS; 4. Occurrence of adverse effects of study drugs; 5. Patient satisfaction with pain relief, using a 5-point Likert scale, at site of inclusion and after three days of pain medication at home; 6. Need for additional pain medication initially and during the following three days; 7. For analysis of quality of life and economic evaluation, health outcomes will be assessed using Euroqol – EQ5D questionnaire. Economic evaluation will include costs-effectiveness analysis up to one month after discharge to measure relevant effects and costs including resource use, costs of care and cost of loss of productivity, compared to national guidelines. Information about hospital admissions or physician’s visits and return to work is also obtained. | — |
Contacts
Public ContactM.L. Ridderikhof
Afdeling Spoedeisende GeneeskundeAcademisch Medisch CentrumMeibergdreef 9
Outcome results
None listed