Back to resultsEffect of Early Pain Management at Triage on Opioid Consumption
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Paracetamol
Tramadol/Paracetamol combination
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Pain focused on measuring acute pain, emergency department, opioid consumption
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
group Placebo
group Paracetamol
group Tramadol/Paracetamol combination
Arm Description
Patients in this group (Placebo Oral Tablet) received two placebo tablets
Patients in this group received two 500 mg paracetamol tablets
Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)
Outcomes
Primary Outcome Measures
use of rescue opioids
decreased consumption of intravenous morphine
Secondary Outcome Measures
patient satisfaction
patient satisfaction regarding the overall management in the emergency department measured by likert scale
Length of emergency department stay
Pain intensity at emergency department discharge
Percentage of patients with visual analog scale <30
Full Information
NCT ID
NCT03243006
First Posted
July 15, 2017
Last Updated
November 28, 2017
Sponsor
University of Monastir
1. Study Identification
Unique Protocol Identification Number
NCT03243006
Brief Title
Effect of Early Pain Management at Triage on Opioid Consumption
Official Title
Effect of Early Analgesic Treatment on Opioid Consumption
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
acute pain, emergency department, opioid consumption
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in this group (Placebo Oral Tablet) received two placebo tablets
Arm Title
group Paracetamol
Arm Type
Active Comparator
Arm Description
Patients in this group received two 500 mg paracetamol tablets
Arm Title
group Tramadol/Paracetamol combination
Arm Type
Active Comparator
Arm Description
Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
2 tablets of 500mg of paracetamol
Intervention Type
Drug
Intervention Name(s)
Tramadol/Paracetamol combination
Intervention Description
2 tablets of tramadol/paracetamol combination (32.5mg/325mg)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
2 tablets of placebo
Primary Outcome Measure Information:
Title
use of rescue opioids
Description
decreased consumption of intravenous morphine
Time Frame
DURING emergency department stay
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
patient satisfaction regarding the overall management in the emergency department measured by likert scale
Time Frame
When quitting emergency department
Title
Length of emergency department stay
Time Frame
Until emergency department discharge
Title
Pain intensity at emergency department discharge
Description
Percentage of patients with visual analog scale <30
Time Frame
At emergency department discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Early Pain Management at Triage on Opioid Consumption
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