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Completed

NCT Number: NCT01782846

Trama-Code (Two Analgesics-comparative Study)

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital FOCH - Emergency unit

Suresnes, Île-de-France Region, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ixprim®

Drug

Dafalgan-Codeine®

Drug

Primary outcomes

  1. pain improvement

    Time frame: 120 minutes

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Trama-Code

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2013
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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