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Effect of Early Pain Management at Triage on Opioid Consumption

NCT ID: NCT03243006

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Acute Pain

Keywords

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acute pain emergency department opioid consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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group Placebo

Patients in this group (Placebo Oral Tablet) received two placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

2 tablets of placebo

group Paracetamol

Patients in this group received two 500 mg paracetamol tablets

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

2 tablets of 500mg of paracetamol

group Tramadol/Paracetamol combination

Patients in this group (Tramadol/Paracetamol combination ) received 2 tablets of Tramadol/Paracetamol combination (37.5mg/325mg)

Group Type ACTIVE_COMPARATOR

Tramadol/Paracetamol combination

Intervention Type DRUG

2 tablets of tramadol/paracetamol combination (32.5mg/325mg)

Interventions

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Paracetamol

2 tablets of 500mg of paracetamol

Intervention Type DRUG

Tramadol/Paracetamol combination

2 tablets of tramadol/paracetamol combination (32.5mg/325mg)

Intervention Type DRUG

Placebo Oral Tablet

2 tablets of placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Triage treatment

Identifier Type: -

Identifier Source: org_study_id