Healthy Skepticism Library item: 9716

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Giraud C, Galene E, Begue D, Tixier C, Clement P.
Use and adverse events of nitrous oxide/oxygen 50/50 mol/mol analgesic mixture: Assessment of cohort temporary authorisation results of SOL France pharmaceutical establishment
Journal de Pharmacie Clinique 2004; 23:(1):5-18

Abstract:

The use of analgesic premixed 50% nitrous oxide and oxygen was under close supervision for drug vigilance during 3.5 years by the French Drug Agency in the field of its therapeutic use, according to the cohort temporary authorization for prescribing medicines. 3 310 sheets were collected by the manufacturer, SOL France. Prescriptions were mainly paediatric (84%). These were isolated (72.1%) or associated with a local anaesthetic or another analgesic. The uses, reported by a majority, amongst these described in the Summary of Product Characteristic, are mainly little superficial surgery and lumbar puncture. The safety of this medicinal gas is excellent. Any really severe side effects, probably imputable to itself alone, have been reported. The incidence of side effects frequency is poor (4.38%) and close from other institutional regular reports but minor to first assessments. The more frequent adverse effects consisted of gastrointestinal (vomiting 47.1%, nausea 9.4%) neuropsychiatric (agitation + anxiety + nervousness 8.0%, euphoria 7.2%, nightmares), and neurological disorders (vertigo 11.6%, headache 10.9%, ebriety). Using this medicinal product without an anaesthetist or a physician familiar to the technology is safe: medical check by a physician of contra-indications, psychotropic associated medicines, potentially respiratory depressive, children above 4 years old. In spite of some limits (under notified side effects) this collected information allowed to enrich the knowledge on the use of this new medicine and to improve the marketing authorisation.