Effect of Early Pain Management at Triage on Opioid Consumption

Not Applicable

Completed

• Conditions: Acute Pain
• Interventions: Drug: Paracetamol; Drug: Placebo Oral Tablet; Drug: Tramadol/Paracetamol combination

• Registration Number: NCT03243006
• Lead Sponsor: University of Monastir

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Study First Submitted: 2017-07-15
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group Paracetamol	Paracetamol	Patients in this group received two 500 mg paracetamol tablets
group Placebo	Placebo Oral Tablet	Patients in this group (Placebo Oral Tablet) received two placebo tablets
group Tramadol/Paracetamol combination	Tramadol/Paracetamol combination	Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)

Primary Outcome Measures

Name	Time	Method
use of rescue opioids	DURING emergency department stay	decreased consumption of intravenous morphine

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	When quitting emergency department	patient satisfaction regarding the overall management in the emergency department measured by likert scale
Length of emergency department stay	Until emergency department discharge
Pain intensity at emergency department discharge	At emergency department discharge	Percentage of patients with visual analog scale \<30