Acute Pain Clinical Trial
— MEOPAOfficial title:
Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain: a Randomized Double-blind Study
Verified date | May 2017 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Less than 10% of patients with a traumatic pain have been managed by a physician before to be admitted in an emergency service. 50 % of those patients have been carried by paramedics. Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged 18 years old - Patients with a moderate acute pain (NRS score between 3 and 6) Exclusion Criteria: - Contraindication of premixed 50% nitrous oxide and oxygen - Recent treatment of analgesic (less than 6 hours) |
Country | Name | City | State |
---|---|---|---|
France | Universty Hospital Toulouse SAMU 31 | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Ducassé JL, Siksik G, Durand-Béchu M, Couarraze S, Vallé B, Lecoules N, Marco P, Lacombe T, Bounes V. Nitrous oxide for early analgesia in the emergency setting: a randomized, double-blind multicenter prehospital trial. Acad Emerg Med. 2013 Feb;20(2):178- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with pain relief Number of patients with pain relief Number of patients with pain relief | Pain is mesured with a numerical rating scale (NRS)score on 10.Pain relief is defined by a NRS score of 3 or less | 15 minutes | |
Secondary | Delay of analgesia (e.g. delay required to obtain analgesia) | Analgesia is obtained when the numerical rating scale score is or less than 3/10 | Every 5 minutes from randomization for a one hour period | |
Secondary | Adverse events | Occurrence of any adverse event from a predefined list. Nausea, Emesis, Dizziness, Drowsiness, Dysphoria, Anxiety, Ear pain | Every 5 minutes from randomization for a one hour period |
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