Nouira Semir
Monastir, 5000, Tunisia
NCT Number: NCT05229965
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Monastir, 5000, Tunisia
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
Other names: 1000mg
14 pills will be provided with a preconised dose of 1 pill 2 times per day over 7 days period
Other names: 500mg/ 30mg
21 pills will be provided with a preconised dose of 1 pill 3 times per day over 7 days period
Other names: 500mg/ 65mg
Time frame: 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 .
Time frame: 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.
Time frame: 7 days from discharge
The patient's need to add another analgesic medication or non-pharmacological analgesic intervention
Time frame: 7 days from discharge
patient satisfaction assessed by Likert's verbal scale : with 3 responses:
University of Monastir
Other
Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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