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

NCT01356745 | Completed Phase 4

• 1 other identifier: 0900603
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

premixed nitrous oxide and oxygen; acute pain; prehospital setting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Every 5 minutes from randomization for a one hour period

• Adverse events

  Every 5 minutes from randomization for a one hour period

Study Arms (2)

premixed 50% nitrous oxide and oxygen

EXPERIMENTAL

Drug: Premixed 50% nitrous oxide and oxygen (Kalinox)

medical air

PLACEBO COMPARATOR

Drug: medical air

Interventions

Premixed 50% nitrous oxide and oxygen (Kalinox) DRUG

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

premixed 50% nitrous oxide and oxygen

medical air DRUG

inhalation gas for inhalation use

medical air

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years old
• Patients with a moderate acute pain (NRS score between 3 and 6)

You may not qualify if:

• Contraindication of premixed 50% nitrous oxide and oxygen
• Recent treatment of analgesic (less than 6 hours)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Universty Hospital Toulouse SAMU 31

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 23406077 RESULT

MeSH Terms

Conditions

Acute Pain

Interventions

Nitrous Oxide; Oxygen; kalinox; Air

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Jean-Louis DUCASSE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: May 19, 2011
• Study Start: February 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

FR (1)