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Intranasal sufentanil given in the emergency department triage zone for severe acute traumatic pain: a randomized double-blind controlled trial

  • Fabien LemoelEmail author
  • Julie Contenti
  • Charles Cibiera
  • Jocelyn Rapp
  • Céline Occelli
  • Jacques Levraut
EM - ORIGINAL

Abstract

The goal of our study was to determine if an intranasal (IN) dose of sufentanil delivered in the ED triage zone would improve the management of severely painful patients. We performed a randomized, double blind and placebo-controlled trial on adult patients suffering from an acute severe pain (≥ 6/10) consecutive to an isolated limb injury. We compared 2 analgesic strategies: the usual pain treatment with IV-only multimodal analgesics (IVMA) including IV opioids if needed (control group) and another strategy (active group) based on a single dose of IN sufentanil (0.4 μg/kg) given at triage and followed by IV multimodal analgesia. Our primary outcome was the proportion of patients reaching pain-relief (≤ 3/10) 30 min after IN injection at triage. Secondary outcomes were rates of adverse events, frequency of clinical interventions required by these events, and satisfaction of patients. A total of 144 adult participants completed the study, 72 in each group. Compared with usual IV-only pain management, the analgesic strategy initiated in triage zone with a dose of IN sufentanil increased the proportion of patients reaching pain relief in 30 min: 72.2% versus 51.4%, in our trial (p = 0.01 and number needed to treat of 5). There was no serious adverse event (AE) in both groups. Patients who received IN sufentanil experienced more frequently minor opiate side effects. Proportion of respiratory AEs was higher in the active group (12.5% of bradypnea < 10 cycles per minute versus 1.4%) but these events were of mild severity, as only 2 participants (one in each group) received temporary low dose oxygen therapy, and none required naloxone. Lengths of stay in the ED were similar in both groups, as well as satisfaction of patients (above 9/10) and pain scores at discharge (< 2/10). We found that a single dose of IN sufentanil delivered in the ED triage zone significantly increases the proportion of severely painful patients reaching painrelief in 30 min, compared to usual analgesia with IV-only multimodal analgesia.

Keywords

Intranasal Sufentanil Non-invasive Acute severe pain Emergency department Triage nurse Limb injury Pain relief delay Time to analgesia 

Notes

Funding

Fondation APICIL, French foundation dedicated to pain, financially supported the trial. Centre Hospitalier Universitaire de Nice financially supported the trial. This work was supported in 2013 by a grant from the Délégation à la Recherche Clinique et à l’Innovation of University Hospital of Nice.

Compliance with ethical standards

Conflicts of interest

All authors declare that they have no conflict of interest.

Statement of human and animal rights

This study has been ethically approved by the Comité de Protection des Personnes Sud Mediterranée V (CHU de NICE - Hôpital de CIMIEZ. Bâtiment Grand Hôtel - 5ème étage. 4 avenue Reine Victoria. CS 91179. 06003 NICE CEDEX 1, France).

Informed consent

All participants provided informed consent.

Supplementary material

11739_2018_2014_MOESM1_ESM.pdf (36 kb)
Supplementary material 1 (PDF 35 kb)

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Copyright information

© Società Italiana di Medicina Interna (SIMI) 2019

Authors and Affiliations

  1. 1.Emergency Department, Hôpital Pasteur 2Centre Hospitalier Universitaire de NiceNiceFrance
  2. 2.School of MedicineUniversité Côte d’AzurNiceFrance

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