Acute Pain Due to Trauma
Conditions
Keywords
acute pain, trauma, paracetamol, codeine, cafeine
Brief summary
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.
Detailed description
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 ) : * Group 1: Paracetamol group who will receive paracetamol ( 1000 mg) : one pill 3 times a day for 7 days . * Group 2: Paracetamol-codeine group who will receive an association of 500 mg of Paracetamol and 30 mg of codeine : one pill twice a day for 7 days . * Group 3: Paracetamol-cafeine group who will receive an association of 500 mg of Paracetamol and 65 mg of cafeine : one pill 3 times a day 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: * Hypertension. * Diabetes. * Respiratory insufficiency. * Renal insufficiency. * Liver failure. * Allergy. And a Clinical examination data: * Pain intensity (NRS). * Mechanism of trauma and site of injury. * Other physical examination data: systolic blood pressure (SBP), heart rate (HR) and temperature. * Nature of traumatic injury. * Final diagnosis * Injury Severity Score (ISS). * NRS at discharge (at rest and on movement). 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: * Satisfied * Moderately satisfied * Not satisfied * Side effects: epigastralgia, dizziness, somnolence, headache, nausea and/or vomiting, insomnia, constipation, palpitation, etc.
Interventions
DRUGParacetamol
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period
DRUGParacetamol caféine
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age :18 years or older * Patients presented to the emergency department with acute post-traumatic pain and residual pain at rest and/or on movement with a numerical pain rating scale (NRS) \> 3/10 on discharge. * They all signed a written consent form.
Exclusion criteria
* Self-mutilation * Severe acute trauma that may require hospitalization * Open or complicated fracture requiring surgical management * Regular use of analgesics * Any known allergy to paracetamol, caffeine or codeine * Asthma and acute/chronic respiratory insufficiency * Severe renal insufficiency (creatinine Cl\<30 ml/min) * Pregnant/lactating women * Hepatic cirrhosis. * Refusal, incapacity or difficulties to consent or to communicate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta Numerical Rating Scale (NRS) ( From 0 to 10 ) | 7 days from discharge | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appearance of side effects | 7 days from discharge | The appearance of side effects such as Drowsiness ,Decreased respiratory rate (\<14 c / min), Cutaneous rash, Vomiting,Nausea,pruritus, Dizziness and Digestive hemorrhage. |
| Need for another analgesic medication or non-pharmacological analgesic intervention | 7 days from discharge | The patient's need to add another analgesic medication or non-pharmacological analgesic intervention |
| Patient satisfaction assessed by Likert's verbal scale at 7 days | 7 days from discharge | patient satisfaction assessed by Likert's verbal scale : with 3 responses: * Satisfied * Moderately satisfied * Not satisfied |
Countries
Tunisia
Outcome results
None listed