A Phase 2/3 interventional study of Premixed 50% nitrous oxide and oxygen and Medical Air in Pain Acute, sponsored by University Hospital, Toulouse. Terminated at 3 sites in 2 countries. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by University Hospital, Toulouse · Phase 2/3, Interventional, and Treatment
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
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 43 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
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
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
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
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
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower)
Time frame: 15 minutes after randomisation
adverse events
Time frame: From the randomization until 48 hours after randomization
time to analgesia
Time frame: From randomization until 48 hours
Duration of analgesia.
Time frame: From randomization until 48 hours
This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse