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The purpose of this study is to:
Compare the effect of paracetamol alone against Paracetamol+Codeine association against the association of paracetamol + Cafeine in the treatment of post-traumatic acute pain of the limbs.
At admission to the emergency department, patients with acute post-traumatic pain will be included, regardless of their initial NRS .These patients will receive the necessary care for their injury (icing, reduction, immobilization, local care, sutures), then went home with a medical prescription and an outpatient appointment .
At discharge and after obtaining their signed consent . All patients included will be randomized according to a numerical randomization table ( assigned in a 1:1:1 ratio) into 3 groups ( As a treatment for their post traumatic pain at discharge for 7 days ) :
For all patients included in the study, demographic and clinical data will be collected by the physician or investigator and recorded on a pre-established form.
The demographic data recorded on each patient's chart were as follows: Age, sex, origin and personal pathological history:
And a Clinical examination data:
Patients included will be assessed at Day 1 , Day 2 , Day 3 and Day 7 after discharge from the emergency department by a telephone call. This evaluation will include :
NRS at rest and during movement
Secondary use of another analgesic.
Patient satisfaction assessed by Likert scale, with 3 responses:
Side effects: epigastralgia, dizziness, somnolence, headache, nausea and/or vomiting, insomnia, constipation, palpitation, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracétamol Group | Active Comparator | In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracétamol Caféine Group) . In Paracetamol group , the patients will receive a pill containing 1000 mg of paracetamol 3 times a day for 7 days . Paracétamol 1000 mg : 1 pill *3 / day |
|
| Paracétamol Codéine Group | Active Comparator | In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol codéine group , the patients will receive a pill containing an association of paracetamol and codéine ( 500mg / 30mg ) 3 times a day for 7 days . -Association of Paracétamol and Codéine ( 500mg / 30 mg) : 1 pill *2 /day |
|
| Paracétamol Caféine Group | Active Comparator | In each study population, the patient will be assigned to one of three treatments (Paracetamol Group or Paracetamol Codéine Group or Paracetamol Caféine Group) . In Paracetamol caféine group , the patients will receive a pill containing an association of paracetamol and caféine ( 500mg / 65 mg ) 3 times a day for 7 days . -Association of Paracétamol and Caféine ( 500mg / 65 mg) : 1 pill *3 /day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | 21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta Numerical Rating Scale (NRS) ( From 0 to 10 ) | Treatment success is defined by the percentage of patients with a reduction in movement NRS at Day 7 discharge (Delta NRS ) ≥ 50% compared with NRS at emergency discharge. ( that mean a better outcome ) Delta NRS ( in movement)=(NRS (at discharge )-NRS (day7))/(NRS (at discharge )) X 100 . | 7 days from discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance of side effects | The appearance of side effects such as Drowsiness ,Decreased respiratory rate (<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage. | 7 days from discharge |
| Need for another analgesic medication or non-pharmacological analgesic intervention |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nouira Semir | Monastir University Hospital, Monastir, Tunisia, 5000 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nouira Semir | 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 |
| C526278 | acetaminophen, codeine drug combination |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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study medications consists of a randomly sequence generated numbers.
patients and the research associate who collected the outcome data are blinded from the study group
| Paracetamol Codeine | Drug | 14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period |
|
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| Paracetamol caféine | Drug | 21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period |
|
|
The patient's need to add another analgesic medication or non-pharmacological analgesic intervention |
| 7 days from discharge |
| Patient satisfaction assessed by Likert's verbal scale at 7 days | patient satisfaction assessed by Likert's verbal scale : with 3 responses:
| 7 days from discharge |
| Aniline Compounds |
| D000588 | Amines |