Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study
Résumé
Background :To show that intranasal Sufentanil (INS) for patients presenting to an emergency department (ED) for acute severe traumatic pain results in a reduction of pain intensity non-inferior to intravenous morphine (IVM).
Design Prospective, randomised, multicentre, non-inferiority trial
Setting Six ED, France.
Participants Patients with non-life threatening trauma pain ≥ 6/10 on numerical pain rating scale (NRS).
Interventions Patients were randomised 1:1 to INS titration (0,3µg/kg and 0,15µg/kg additional dose at 10 min and 20 min if NRS>3) and IV placebo; or to IVM (0,1 mg/kg and 0,05 mg/kg additional dose at 10 min and 20 min if NRS>3) and IN placebo. Patients, clinical and research staff were blinded to the treatment allocation except the nurse in charge of the treatment preparation.
Main outcome measures The primary endpoint was the total decrease on NRS at 30 min after first administration. The prespecified noninferiority margin was 1.3 on the NRS. We collect all adverse events, symptoms and patients’ satisfaction. Primary outcome was analyzed per protocol.
Results A total of 157 patients were enrolled in the trial and randomised between 80 IVM and 77 INS, among the protocol design was adequately administered on 136 (69 group IVM, 67 group INS, per protocol analysis).
The mean NRS difference between 30 min and first administration was -4.1 (-4.6 to -3.6) in the IVM group and -5.2 (-5.7 to -4.7) in the INS group. Non-inferiority was met (p<0.001 for non-inferiority), as the lower 97.5% confidence interval of 0.29 was smaller than the prespecified noninferiority margin of 1.3. INS was superior to IVM (p=0.001 for superiority) and no differences were observed in terms of adverse events incidence.
Conclusions
Intranasal Sufentanil is non-inferior and superior to intravenous morphine for pain reduction in 30 minutes in patients with severe traumatic pain presenting to the ED.
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