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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01356745
First received: June 22, 2010
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Acute Pain
Drug: Premixed 50% nitrous oxide and oxygen (Kalinox)
Drug: medical air
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain: a Randomized Double-blind Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Number of patients with pain relief Number of patients with pain relief Number of patients with pain relief [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Delay of analgesia (e.g. delay required to obtain analgesia) [ Time Frame: Every 5 minutes from randomization for a one hour period ] [ Designated as safety issue: No ]
    Analgesia is obtained when the numerical rating scale score is or less than 3/10

  • Adverse events [ Time Frame: Every 5 minutes from randomization for a one hour period ] [ Designated as safety issue: Yes ]
    Occurrence of any adverse event from a predefined list. Nausea, Emesis, Dizziness, Drowsiness, Dysphoria, Anxiety, Ear pain


Enrollment: 60
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356745

Locations
France
Universty Hospital Toulouse SAMU 31
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jean-Louis DUCASSE, MD University Hospital, Toulouse
  More Information

No publications provided by University Hospital, Toulouse

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01356745     History of Changes
Other Study ID Numbers: 0900603
Study First Received: June 22, 2010
Last Updated: April 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
premixed nitrous oxide and oxygen
acute pain
prehospital setting

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014