Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay

Phase 4

Completed

• Conditions: Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)
• Interventions: Drug: Placebo; Drug: Sufentanil

• Registration Number: NCT01954368
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Time to pain-relief can vary widely in the Emergency Department (ED), depending on various factors such as ED overcrowding or inadequate training in pain management.

As intravenous (IV) opioid administration is world-wide recommended for severe pain treatment, delays from triage to room admission and to first IV injection directly influence this time to pain-relief. Moreover, it is proven that an incorrect adherence to morphine titration protocol can participate in ED oligoanalgesia.

Although ED experience in intranasal (IN) opioid administration is still lacking, this simple and non-invasive way of treating pain seems safe and promising. Opioid pharmacokinetic by IN route indeed is interesting for ED practitioners : while assuring a timely analgesia, the lower Cmax and delayed Tmax by IN route can theoretically limit the risk of respiratory depression, in comparison with IV route.

We propose a randomized double-blind placebo-controlled study on a convenience sample of adult patients admitted in our ED (annual census of 80000 attendances) for an isolated limb injury, and experiencing a severe pain (score \> 5/10 on numerical pain scale).

For primary outcome, we will compare the proportion of patients relieved (score \< 4/10) 30 minutes after admission, depending on the administration (or not) of a single intranasal dose of sufentanil (0,4 mcg/kg) given by the triage nurse.

Other secondary outcomes will include : evolution of pain scores in the first hour of admission and during entire ED stay, proportions of opioid-induced side-effects, proportions of patients receiving morphine and doses of morphine administrated, times for discharge, patient and staff satisfaction scores.

Study Timeline

• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Study Start: 2014-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal placebo	Placebo	Patients receiving intranasal placebo at ED admission
Intranasal sufentanil	Sufentanil	Patients receiving intranasal sufentanil at ED admission

Primary Outcome Measures

Name	Time	Method
Pain relief assessment	30 minutes after ED admission	Proportion of patients pain-relieved (score \< 4/10 on numerical pain scale) at T30 (30 minutes after their admission)

Secondary Outcome Measures

Name	Time	Method
Pain assessment	30 minutes after ED admission	Proportions of patients having a score on numerical pain scale \< 6/10 at room admission.
opioids-related side-effects	2h after last opioid injection.	Proportions of opioids-related side-effects.
time to pain relief treatment	30 minutes after ED admission	Delay from ED admission to first opioid injection (IV morphine or IN sufentanil).
Patient satisfaction	at discharge	Patient satisfaction score at discharge (an average time of 12h) (on a " zero-to-10 " scale)
ED length of stay	8 h after ED admission	ED length of stay.
Nurse satisfaction	at discharge	Nurse satisfaction score at discharge (an average time of 12h)(on a " zero-to-10 " scale)
Delay from first opioid injection to pain-relief	30 minutes	Delay from first opioid injection (IV morphine or IN sufentanil) to pain-relief.

Trial Locations

Locations (1)

Emergency Department; 🇫🇷 Nice, France