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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
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.
Emergency Department
Nice, France
Pain relief assessment
Proportion of patients pain-relieved (score \< 4/10 on numerical pain scale) at T30 (30 minutes after their admission)
Time frame: 30 minutes after ED admission
opioids-related side-effects
Proportions of opioids-related side-effects.
Time frame: 2h after last opioid injection.
Pain assessment
Proportions of patients having a score on numerical pain scale \< 6/10 at room admission.
Time frame: 30 minutes after ED admission
time to pain relief treatment
Delay from ED admission to first opioid injection (IV morphine or IN sufentanil).
Time frame: 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.
Time frame: 30 minutes
Patient satisfaction
Patient satisfaction score at discharge (an average time of 12h) (on a " zero-to-10 " scale)
Time frame: at discharge
ED length of stay
ED length of stay.
Time frame: 8 h after ED admission
Nurse satisfaction
Nurse satisfaction score at discharge (an average time of 12h)(on a " zero-to-10 " scale)
Time frame: at discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.