NCT03243006

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

July 15, 2017

Last Update Submit

November 28, 2017

Conditions

Acute Pain

Keywords

acute painemergency departmentopioid consumption

Outcome Measures

Primary Outcomes (1)

  • use of rescue opioids

    decreased consumption of intravenous morphine

    DURING emergency department stay

Secondary Outcomes (3)

  • patient satisfaction

    When quitting emergency department

  • Length of emergency department stay

    Until emergency department discharge

  • Pain intensity at emergency department discharge

    At emergency department discharge

Study Arms (3)

group Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

group Paracetamol

ACTIVE COMPARATOR

Patients in this group received two 500 mg paracetamol tablets

Drug: Paracetamol

group Tramadol/Paracetamol combination

ACTIVE COMPARATOR

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

Drug: Tramadol/Paracetamol combination

Interventions

ParacetamolDRUG

2 tablets of 500mg of paracetamol

group Paracetamol
Tramadol/Paracetamol combinationDRUG

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

group Tramadol/Paracetamol combination
Placebo Oral TabletDRUG

2 tablets of placebo

group Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute PainEmergencies

Interventions

AcetaminophenTramadol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 15, 2017

First Posted

August 8, 2017

Study Start

January 1, 2016

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

November 30, 2017

Record last verified: 2017-11