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

Acute Severe Traumatic Pain in the ED : Can we Improve Time to Pain-relief With a Single Dose of Intranasal Sufentanil Given at Triage ? A Randomized Double-blinded Placebo Controlled Study (InSPEED Study)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Emergency department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Intranasal placebo; Patients receiving intranasal placebo at ED admission	Drug: Placebo; 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.
Experimental: Intranasal sufentanil; Patients receiving intranasal sufentanil at ED admission	Drug: Sufentanil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: 13-AOI-10; 2013-003308-38 (EudraCT Number)