Trama-Code (Two Analgesics-comparative Study)
Phase 4
Completed
- Conditions
- Pain
- Interventions
- Drug: Dafalgan-Codeine®Drug: Ixprim®
- Registration Number
- NCT01782846
- Lead Sponsor
- Hopital Foch
- Brief Summary
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.
The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 803
Inclusion Criteria
- Patients of 18 - 75 years of age
- Presented to the emergency unit of FOCH hospital
- Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse
Read More
Exclusion Criteria
- Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours
- pregnant or lactating females
- Patient with one or more contraindication to one of the study drugs
- Patients for whom the pain assessment scale can not be performed (unconscious, confused ...)
- Patient cannot be included for legal reasons
- Patient required urgent management
- Patient for whom it is considered difficult to be reassessed 2 hours later
- Patient unable to swallow
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dafalgan Codeine® Dafalgan-Codeine® Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine) Ixprim® Ixprim® 2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol)
- Primary Outcome Measures
Name Time Method pain improvement 120 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital FOCH - Emergency unit
🇫🇷Suresnes, Ile de France, France