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

NCT ID: NCT01990404

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

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

Detailed Description

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 108 patients assigned in two parallel groups, defined by a randomization scheme. Four sites will participate to the research. Eligible patients with a numeric rating scale (NRS) score higher than 6/10 are randomly allocated to receive either MEOPA, or medical air. Neither the investigator nor the nurse knows the treatment. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, and oxygen saturation by pulse oximetry (SpO2) and adverse events collection.

Conditions

Pain Acute

Study Design

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

Study Groups

Premixed 50% nitrous oxide and oxygen

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.

Group Type: ACTIVE_COMPARATOR

Premixed 50% nitrous oxide and oxygen

Intervention Type: 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.

Medical air

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.

Group Type: PLACEBO_COMPARATOR

Medical Air

Intervention Type: 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

Interventions

Premixed 50% nitrous oxide and oxygen

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.

Intervention Type: DRUG

Medical Air

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

Intervention Type: DRUG

Other Intervention Names

MEOPA

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Contraindication of premixed 50% nitrous oxide and oxygen

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Bounes, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

SAMU Bobigny

Bobigny, , France

SAMU Toulouse

Toulouse, , France

SAMU St-Denis de la Réunion

Saint-Denis, , Reunion

Countries

France; Reunion

References

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.

Reference Type: BACKGROUND

PMID: 8924137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15039693 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15241964 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9864128 (View on PubMed)

Other Identifiers

2012-004129-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RC31/12/066

Identifier Type: -

Identifier Source: org_study_id