drugset / Trial / NCT01356745

Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain

NCT01356745 ↗

Phase 4 Completed 60 enrolled University Hospital, Toulouse
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Less than 10% of patients with a traumatic pain have been managed by a physician before to be admitted in an emergency service. 50 % of those patients have been carried by paramedics. Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.

Timeline

Start
2010-02
Primary completion
2011-05
Completion
2011-05

Outcome

Met primary endpoint

paper At T15, 67% of the patients in the N(2) O group had an NRS score of 3 or lower versus 27% of those in the MA group (delta = 40%, 95% confidence interval [CI] = 17% to 63%; p < 0.001). PMID 23406077 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Kalinox Unknown 50 % Inhaled

Indications

No indication recorded.