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

NCT ID: NCT01356745

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-05-31

Brief 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.

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

premixed 50% nitrous oxide and oxygen

Group Type: EXPERIMENTAL

Premixed 50% nitrous oxide and oxygen (Kalinox)

Intervention Type: DRUG

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

medical air

Group Type: PLACEBO_COMPARATOR

medical air

Intervention Type: DRUG

inhalation gas for inhalation use

Interventions

Premixed 50% nitrous oxide and oxygen (Kalinox)

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

Intervention Type: DRUG

medical air

inhalation gas for inhalation use

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis DUCASSE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Universty Hospital Toulouse SAMU 31

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 23406077 (View on PubMed)

Other Identifiers

0900603

Identifier Type: -

Identifier Source: org_study_id