Intranasal Sufentanil Pain-management at Entrance of Emergency Department : Influence on Pain-relief Delay
Condition: Single Traumatic Limb Injury With Severe Pain (Score > 5/10 on Numerical Pain Scale)
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Placebo; Sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment