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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03243006
Other study ID # Triage treatment
Secondary ID
Status Completed
Phase N/A
First received July 15, 2017
Last updated November 28, 2017
Start date January 1, 2016
Est. completion date September 30, 2016

Study information

Verified date November 2017
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

introduction: Pain remains one of the most common reasons of emergency department admission. Opioids are overprescribed in emergency departments to treat severe pain.

objective: assessing the impact of ealy pain pain management on the use of intravenous morphine and on patient satisfaction.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date September 30, 2016
Est. primary completion date September 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- over 18 years of age

- a visual analog scale (VAS) equal to or higher than 30/100 ,

- having given consent to participation

- No contraindications to products used in the course of the study.

Exclusion Criteria:

- having a vital distress that does not allow an adequate assessment of the intensity of the pain

- an inability to assess pain intensity according to the VAS,

- swallowing disorders or inability , or a contraindication or an allergy to the treatments used.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Paracetamol
2 tablets of 500mg of paracetamol
Tramadol/Paracetamol combination
2 tablets of tramadol/paracetamol combination (32.5mg/325mg)
Placebo Oral Tablet
2 tablets of placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Outcome

Type Measure Description Time frame Safety issue
Primary use of rescue opioids decreased consumption of intravenous morphine DURING emergency department stay
Secondary patient satisfaction patient satisfaction regarding the overall management in the emergency department measured by likert scale When quitting emergency department
Secondary Length of emergency department stay Until emergency department discharge
Secondary Pain intensity at emergency department discharge Percentage of patients with visual analog scale <30 At emergency department discharge
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