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

Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain: a Randomized Double-blind Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Premixed 50% nitrous oxide and oxygen (Kalinox); Drug: medical air

Detailed Description

The study will evaluate the efficacy of premixed nitrous oxide and oxygen (MEOPA) in patients with out-of-hospital moderate acute pain.

The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) 15 minutes after randomisation. Secondary endpoints are treatment safety and adverse events, time to analgesia and duration of analgesia. This study will expect 60 patients assigned in two parallel groups, defined by a randomization scheme. Group assignments were sealed in opaque envelopes and will be open sequentially by the dispatcher when the paramedic is ready to include the patient. The letter contained in the envelope corresponds to the cylinder to use. Eligible patients with a numeric rating scale (NRS) score between 3 and 6/10 are randomly allocated to receive either MEOPA, or medical air. Fifteen minutes after the randomisation, all patients will receive MEOPA from a distinct cylinder. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The paramedic blinded to the analgesic treatment groups will do all assessments of patients. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, oxygen saturation by pulse oximetry (SpO2) and adverse events collection.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Universty Hospital Toulouse SAMU 31

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18 years old
• Patients with a moderate acute pain (NRS score between 3 and 6)

Exclusion Criteria:

• Contraindication of premixed 50% nitrous oxide and oxygen
• Recent treatment of analgesic (less than 6 hours)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: premixed 50% nitrous oxide and oxygen	Drug: Premixed 50% nitrous oxide and oxygen (Kalinox); 15 min inhalation dose (maximum duration of treatment of a subject)
Placebo Comparator: medical air	Drug: medical air; inhalation gas for inhalation use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with pain relief Number of patients with pain relief Number of patients with pain relief	Pain is mesured with a numerical rating scale (NRS)score on 10.Pain relief is defined by a NRS score of 3 or less	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay of analgesia (e.g. delay required to obtain analgesia)	Analgesia is obtained when the numerical rating scale score is or less than 3/10	Every 5 minutes from randomization for a one hour period
Adverse events	Occurrence of any adverse event from a predefined list. Nausea, Emesis, Dizziness, Drowsiness, Dysphoria, Anxiety, Ear pain	Every 5 minutes from randomization for a one hour period

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Jean-Louis DUCASSE, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• Ducasse JL, Siksik G, Durand-Bechu M, Couarraze S, Valle B, Lecoules N, Marco P, Lacombe T, Bounes V. Nitrous oxide for early analgesia in the emergency setting: a randomized, double-blind multicenter prehospital trial. Acad Emerg Med. 2013 Feb;20(2):178-84. doi: 10.1111/acem.12072.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: acute pain; prehospital setting; premixed nitrous oxide and oxygen
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 0900603