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

Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain: a Randomized Double-blind Study

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01990404

Acronym

MEOPA-PA

Enrollment

Registered

2013-11-21

Start date

2013-07-31

Completion date

2016-06-30

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Acute

Keywords

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

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.

Interventions

DRUGPremixed 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.

DRUGMedical 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

65 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France, Reunion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026