Clinical trial NCT01954368: Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain relief assessment
timeFrame: 30 minutes after ED admission
Secondary outcomes:
measure: opioids-related side-effects
timeFrame: 2h after last opioid injection.
measure: Pain assessment
timeFrame: 30 minutes after ED admission
measure: time to pain relief treatment
timeFrame: 30 minutes after ED admission
measure: Delay from first opioid injection to pain-relief
timeFrame: 30 minutes
measure: Patient satisfaction
timeFrame: at discharge
measure: ED length of stay
timeFrame: 8 h after ED admission
measure: Nurse satisfaction
timeFrame: at discharge
Other outcomes:
Locations:
city: Nice
country: France
facility: Emergency Department
Study officials:
References: