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The purpose of this study is to:
Compare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.
Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.
All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parcetamol Group | Active Comparator | The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card. |
|
| NSAID Group | Active Comparator | The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card. |
|
| NSAID + Paracetamol Group | Active Comparator | The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | 21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period |
|
| Measure | Description | Time Frame |
|---|---|---|
| new oral analgesic medications needed rate | oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition | 3 days and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later | [delta VNS= (VNS D0 - VNS D7 / VNS D0) x 100] | 3 and 7 days |
| The appearance of side effects |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, MD | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monastir University Hospital | Monastir | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D010894 | Piroxicam |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Subjects are randomized in 3 arms:
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study medications consists of identical shape pills of each study medication randomization is made by sealed envelops and a randomly sequence generated numbers.
patients and the research associate who collected the outcome data are blinded from the study group
| NSAID | Drug | 14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period |
|
|
| paracetamol-NSAID | Drug | 21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period |
|
|
The appearance of side effects: such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness.
• Digestive hemorrhage.
| 7 days |
| the rate of ED readmissions for residual pain | ED readmissions for residual pain | 3 and 7 days |
| patient satisfaction assessed by Likert's verbal scale. | patient satisfaction assessed by Likert's verbal scale. | 3 and 7 days |
| Aniline Compounds |
| D000588 | Amines |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |