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

NCT01990404 | Terminated Phase 2

• 2 other identifiers: RC31/12/0662012-004129-25
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 3

Brief Summary

Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. None randomized study has validated the use of premixed nitrous oxide and oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with out-of-hospital severe acute pain

Conditions

Pain Acute

Keywords

Premixed nitrous oxide and oxygen; Severe acute pain; Prehospital setting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• adverse events

  From the randomization until 48 hours after randomization

• time to analgesia

  From randomization until 48 hours

• Duration of analgesia.

  From randomization until 48 hours

Study Arms (2)

Premixed 50% nitrous oxide and oxygen

ACTIVE COMPARATOR

The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. Premixed 50% nitrous oxide and oxygen is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN \<3/10.

Drug: Premixed 50% nitrous oxide and oxygen

Medical air

PLACEBO COMPARATOR

The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. The medical air is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN \<3/10.

Drug: Medical Air

Interventions

Premixed 50% nitrous oxide and oxygen DRUG

Premixed 50% nitrous oxide and oxygen is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B.

Also known as: MEOPA

Premixed 50% nitrous oxide and oxygen

Medical Air DRUG

Medical air is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B

Medical air

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 65 years old and over
• Severe acute pain (NRS score greater than 6)

You may not qualify if:

• Contraindication of premixed 50% nitrous oxide and oxygen

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

SAMU Bobigny

Bobigny, 93000, France

Location

SAMU Toulouse

Toulouse, 31059, France

Location

SAMU St-Denis de la Réunion

Saint-Denis, 97405, Reunion

Location

Related Publications (4)

• Jones JS, Johnson K, McNinch M. Age as a risk factor for inadequate emergency department analgesia. Am J Emerg Med. 1996 Mar;14(2):157-60. doi: 10.1016/S0735-6757(96)90123-0.

  PMID: 8924137 BACKGROUND

• Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.

  PMID: 15039693 BACKGROUND

• Doan BD. [Aging of population and medical workforce: a prospective view of health care provision in France in the year 2025]. Cah Sociol Demogr Med. 2004 Apr-Jun;44(2):243-66. French.

  PMID: 15241964 BACKGROUND

• Strange GR, Chen EH. Use of emergency departments by elder patients: a five-year follow-up study. Acad Emerg Med. 1998 Dec;5(12):1157-62. doi: 10.1111/j.1553-2712.1998.tb02688.x.

  PMID: 9864128 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Nitrous Oxide; Oxygen; Meopa; 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

• Vincent Bounes, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: November 21, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

RE (1); FR (2)