Effect of Early Pain Management at Triage on Opioid Consumption

November 28, 2017 updated by: Pr. Semir Nouira, University of Monastir

Effect of Early Analgesic Treatment on Opioid Consumption

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group Placebo
Patients in this group (Placebo Oral Tablet) received two placebo tablets
Drug: Placebo Oral Tablet
2 tablets of placebo
Active Comparator: group Paracetamol
Patients in this group received two 500 mg paracetamol tablets
Drug: Paracetamol
2 tablets of 500mg of paracetamol
Active Comparator: group Tramadol/Paracetamol combination
Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)
Drug: Tramadol/Paracetamol combination
2 tablets of tramadol/paracetamol combination (32.5mg/325mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
use of rescue opioids
Time Frame: DURING emergency department stay
decreased consumption of intravenous morphine
DURING emergency department stay

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

July 15, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Triage treatment

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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