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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Premixed 50% nitrous oxide and oxygen (Kalinox)
* Drug: medical air


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premixed nitrous oxide and oxygen, acute pain, prehospital setting