NCT01954368

Brief Summary

Non-invasive and simple, intranasal (IN) route of administration seems promising for pain management in the Emergency Department (ED), especially when used precociously by triage nurse to rapidly deliver the first opioid dose to severely painful patients. This randomized double-blind placebo-controlled study will focus on severe traumatic pain experienced by adults admitted in our ED. We hypothesized that, in addition to traditional morphine titration, a single dose of IN sufentanil given at triage would significantly increase the proportion of patients relieved 30 minutes after their ED admission. Time to discharge, proportion of side effects and satisfaction rates will also be recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 20, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

September 20, 2013

Last Update Submit

November 30, 2016

Conditions

Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)

Outcome Measures

Primary Outcomes (1)

  • Pain relief assessment

    Proportion of patients pain-relieved (score \< 4/10 on numerical pain scale) at T30 (30 minutes after their admission)

    30 minutes after ED admission

Secondary Outcomes (7)

  • opioids-related side-effects

    2h after last opioid injection.

  • Pain assessment

    30 minutes after ED admission

  • time to pain relief treatment

    30 minutes after ED admission

  • Delay from first opioid injection to pain-relief

    30 minutes

  • Patient satisfaction

    at discharge

  • +2 more secondary outcomes

Study Arms (2)

Intranasal placebo

PLACEBO COMPARATOR

Patients receiving intranasal placebo at ED admission

Drug: Placebo

Intranasal sufentanil

EXPERIMENTAL

Patients receiving intranasal sufentanil at ED admission

Drug: Sufentanil

Interventions

PlaceboDRUG

As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a planned weight-based volume of intranasal placebo (normal saline solution). Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.

Intranasal placebo
SufentanilDRUG

As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a weight-based volume (corresponding to 0,4 mcg/kg) of intranasal sufentanil. Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse.

Intranasal sufentanil

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single traumatic limb injury.
  • Severe pain (score \> 5/10 on numerical pain scale)
  • Age ≥ 18 years and \< 75 years

You may not qualify if:

  • Abdominal, thoracic, vertebral or cranial injury associated
  • Hemodynamic instability (systolic blood pressure \< 100 mmHg and/or blood pulse \> 110 / min)
  • Oxygen saturation \< 96% on room air
  • Chronic respiratory, renal or cardiac failure
  • Impaired mental status (Glasgow Coma Scale \< 15)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department

Nice, 06000, France

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 1, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

FR(1)