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

Acute Pain Clinical Trial

— MEOPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356745
• Other study ID #: 0900603
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2010
• Last updated: May 10, 2017
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Premixed 50% nitrous oxide and oxygen (Kalinox)
15 min inhalation dose (maximum duration of treatment of a subject)
• medical air
inhalation gas for inhalation use

Locations

Country	Name	City	State
France	Universty Hospital Toulouse SAMU 31	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Ducassé JL, Siksik G, Durand-Béchu M, Couarraze S, Vallé 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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