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

Pain Acute Clinical Trial

— MEOPA-PA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01990404
• Other study ID #: RC31/12/066
• Secondary ID: 2012-004129-25
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 27, 2013
• Last updated: February 2, 2018
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: February 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain Acute

Intervention

Drug:
• 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.
• 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

Locations

Country	Name	City	State
France	SAMU Bobigny	Bobigny
France	SAMU Toulouse	Toulouse
Réunion	SAMU St-Denis de la Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Countries where clinical trial is conducted

France,  Réunion, 

References & Publications (4)

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. — View 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. — View Citation

Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse events		From the randomization until 48 hours after randomization
Secondary	time to analgesia		From randomization until 48 hours
Secondary	Duration of analgesia.		From randomization until 48 hours