Trama-Code (Two Analgesics-comparative Study)

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Dafalgan-Codeine®; Drug: Ixprim®

Study type: Interventional

Funder types: Other

Identifiers

NCT01782846

2010/45

Details and patient eligibility

About

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).

Enrollment: 803 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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803 participants in 2 patient groups

Ixprim®

Active Comparator group

Description:

2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol)

Treatment:

Drug: Ixprim®

Dafalgan Codeine®

Active Comparator group

Description:

Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine)

Treatment:

Drug: Dafalgan-Codeine®