|- candidate number||14844|
|- NTR Number||NTR3982|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2013|
|- Secondary IDs||NL42823.018.13 CCMO|
|- Public Title||Paracetamol or NSAID's in minor musculoskeletal trauma.|
|- Scientific Title||Paracetamol or NSAID's in acute musculoskeletal syndromes.|
|- ACRONYM||PanAM Study|
|- hypothesis||Paracetamol is not inferior to Diclofenac or the combination of Paracetamol + Diclofenac in treating pain in adult patients with acute traumatic musculoskeletal complaints.|
|- Healt Condition(s) or Problem(s) studied||Analgesia, Acute musculoskeletal syndromes, Minor injuries|
|- 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||1. Previous treatment with analgesia for the same injury;|
2. Self inflicted injury (ďauto-mutilationĒ);
3. Presence of wound, joint dislocation, fracture or more then one injury;
4. Daily use of paracetamol and/or NSAIDís and/or other analgesia within two weeks before presentation;
5. Patients with chronic pain;
6. Previous adverse reaction or known allergy to paracetamol, NSAIDís or omeprazol;
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 NSAIDís 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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-jun-2013|
|- planned closingdate||20-jun-2014|
|- Target number of participants||547|
|- 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 blinded drugs, all patients will take (non-blinded) Omeprazol 20 mg once daily during these three days (starting at site of presentation).
|- Primary outcome||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 outcome||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% or >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 Ė 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 physicianís visits and return to work is also obtained.
|- Timepoints||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.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M.L. Ridderikhof|
|- CONTACT for SCIENTIFIC QUERIES|| M.L. Ridderikhof|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Pain medication in patients with acute musculoskeletal syndromes is frequently
prescribed at the treating physicianís discretion and preferences. There is no convincing evidence about superiority of paracetamol or Non-Steroidal Anti-Inflammatory Drugs (NSAIDís) in these patients. Mainly NSAIDís can have detrimental adverse events. It is indicated to investigate which pharmacologic pain treatment is superior in managing pain in acute musculoskeletal syndromes.
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.
Double-blind randomized controlled trial (RCT) with non-inferiority design.
Adult patients, aged ≥ 18 years, presenting to the Emergency Department or in general practice with acute (<48 hours) blunt, traumatic limb injury.
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 NSAIDís. Strict exclusion criteria are maintained.
|- Main changes (audit trail)|
|- RECORD||2-mei-2013 - 20-mei-2013|