Trama-Code (Two Analgesics-comparative Study)

Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01782846

Acronym

Trama-Code

Enrollment

803

Registered

2013-02-04

Start date

2011-03-31

Completion date

2013-04-30

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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).

Interventions

DRUGIxprim®

DRUGDafalgan-Codeine®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
pain improvement	120 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026