Clinical trial NCT01990404: Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain
Official title: Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pain Acute
Keywords: Premixed nitrous oxide and oxygen
Severe acute pain
Prehospital setting
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 43
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower)
timeFrame: 15 minutes after randomisation
Secondary outcomes:
measure: adverse events
timeFrame: From the randomization until 48 hours after randomization
measure: time to analgesia
timeFrame: From randomization until 48 hours
measure: Duration of analgesia.
timeFrame: From randomization until 48 hours
Other outcomes:
Locations:
city: Bobigny
country: France
facility: SAMU Bobigny
city: Toulouse
country: France
facility: SAMU Toulouse
city: Saint-Denis
country: Réunion
facility: SAMU St-Denis de la Réunion
Study officials:
affiliation: University Hospital of Toulouse
name: Vincent Bounes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.