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NCT Number: NCT01356745

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universty Hospital Toulouse SAMU 31

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Premixed 50% nitrous oxide and oxygen (Kalinox)

Drug

15 min inhalation dose (maximum duration of treatment of a subject)

Medical Air

Drug

inhalation gas for inhalation use

Primary outcomes

  1. Number of patients with pain relief Number of patients with pain relief Number of patients with pain relief

    Time frame: 15 minutes

    Pain is mesured with a numerical rating scale (NRS)score on 10.Pain relief is defined by a NRS score of 3 or less

Secondary outcomes

  1. Delay of analgesia (e.g. delay required to obtain analgesia)

    Time frame: Every 5 minutes from randomization for a one hour period

    Analgesia is obtained when the numerical rating scale score is or less than 3/10

  2. Adverse events

    Time frame: Every 5 minutes from randomization for a one hour period

    Occurrence of any adverse event from a predefined list. Nausea, Emesis, Dizziness, Drowsiness, Dysphoria, Anxiety, Ear pain

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: MEOPA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 19, 2011
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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