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NITROUS OXIDE is a brand name for Nitrous Oxide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Nitrous oxide Medicinal SOL in equimolar concentration with oxygen (50% v/v nitrous oxide and 50% v/v oxygen) is indicated for the treatment of short-term pain conditions of mild to moderate intensity when rapid analgesic onset and offset effects are required, in adults and in children older than 1 month. • Nitrous…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Analgesia Administration of Nitrous oxide Medicinal SOL in an equimolar mixture with oxygen should commence shortly before the desired analgesic effect is required. The analgesic effect is seen after 4-5 breaths and reaches its maximum within 2-3 minutes.
Administration of Nitrous oxide Medicinal SOL should continue throughout the painful procedure, or for as long as the analgesic effect is desired. Following discontinuation of the administration/inhalation, the effects wear off quickly within a few minutes.
According to the individual pain-relieving reaction in the patient, additional analgesics may be required. Nitrous oxide, as an analgesic, in an equimolar mixture with oxygen, may not be administered for longer than 1 hour continuously and should not be used for more than 15 consecutive days.
Anaesthesia Nitrous oxide acts as a basal anaesthetic to achieve anaesthesia. Nitrous oxide alone, with a maximum permitted concentration of 79 % v/v, cannot induce anaesthesia. In combination with other inhalation anaesthetics, nitrous oxide provides accelerated uptake of both inhalation anaesthetics by means of what is known as the “concentration and second gas” effect.
Induction time is 2 – 5 minutes. Nitrous oxide concentration during the induction phase is no more than 79 % v/v. After the induction phase, the quantity of nitrous oxide required as basic anaesthetic is between 50 and 70 % v/v, supplemented by medical oxygen.
The quantity of the second inhalation anaesthetic required decreases by about 1 % of its minimal alveolar concentration (MAC) for every 1 % of volume of nitrous oxide inhaled. Refer to the relevant product information for maintenance dosages of nitrous oxide and additional inhalation anaesthetic.
In the event of combination with intravenous anaesthetic, a reduced dose of the intravenous anaesthetic, based on the theoretical minimal alveolar concentration value for nitrous oxide (approximately 105% v/v) is calculated in advance and administered.
The inhaled concentration of nitrous oxide should not exceed 70% v/v and should be adjusted downwards depending on clinical parameters. Continuous exposure (>24 hours) to nitrous oxide increases the risk of bone marrow depression. 9).
Method of administration For inhalation use. Nitrous oxide is administered only after mixing with at least 21% oxygen, using appropriate equipment and a well-fitting mask. Nitrous oxide should only be administered by adequately trained personnel, and according to local guidelines.
The known undesirable effects are classified according to the various organ systems. Frequency-based classification is not really possible because no structured trials have been carried out in this context. If a reasonable estimation of frequency can be made on the basis of the literature, this has been indicated in the overview below.
Frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (isolated reports) (<1/10,000); not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Severe haematological disorders (megaloblastic anaemia, granulocytopenia) have been observed after administration for longer than 24 hours. It is assumed that a single exposure for up to 6 hours involves no risk.
Psychiatric Disorders:
Psychoses, confusion, anxiolytic and euphoric effects, headache. Addiction may occur (frequency not known).
Nervous system disorders:
Decrease in local cerebral blood circulation and local cerebral glucose consumption. Psychodysleptic effects may occur in the absence of combination with another anaesthetic agent. Combination of this type is normal because nitrous oxide acts solely to mediate narcotic effects.
Neurological effects: epilepsy, generalised seizures (frequency not known), sedation, dizziness, increased intracranial pressure, spastic paraparesis. Neurological effects such as neuropathy, pins and needles throughout the body, myeloneuropathy and subacute degeneration of the spinal cord (frequency not known), have been reported with exceptionally high and frequent exposure.
Nitrogen should be expelled from the administration equipment prior to administration because of the high concentrations of nitrous oxide generally used for induction. The patient must be hyperventilated with oxygen at the same time.
The oxygen fraction in the inspired gas mixture (FiO2) must be kept at a minimum of 21% during the induction phase. 30% is often used as the lower threshold in practice. The inspired oxygen fraction may be increased to 100% if necessary.
0 kPa or 60 mmHg with haemoglobin oxygen saturation > 90%. Regular monitoring by measuring arterial oxygen tension (PaO2) or using pulse oximetry (arterial oxygen saturation (SpO2)) and by means of clinical assessment is mandatory. The aim is to achieve effective oxygen concentration in the inspiration air that is as low as possible for the individual patient.
In unexpected cases of cyanosis during anaesthesia with a device delivering oxygen and nitrous oxide, the first step should be to stop the flow of nitrous oxide. If the cyanosis does not rapidly disappear, the patient must be ventilated with a bag filled with air.
If the cyanosis recurs, anaesthesia treatment in the treatment room should be discontinued and the gases being delivered through the relief valves should be analysed. Hypoxia may develop after stopping the administration of the nitrous oxide/oxygen mixture, resulting from the excretion of nitrous oxide from the body into the lungs.
It is recommended that the lungs be temporarily ventilated with 100% medical oxygen after discontinuation of the administration of nitrous oxide. Oxygen tension and saturation monitoring should be continued for 15 minutes after the end of the administration of nitrous oxide.
Repeated administration or exposure to nitrous oxide may lead to addiction. Caution should be exercised in patients with a known history of substance abuse or in healthcare professionals with occupational exposure to nitrous oxide. g.
Patients for whom ventilation with 100% medicinal oxygen is indicated. For analgesic use in patients with a decreased level of consciousness or impaired ability to cooperate and follow instructions due to the risk that further sedation from the nitrous oxide may affect natural protective reflexes.
Conditions associated with body cavities containing gas (pneumothorax, bullous emphysema, Caisson disease or decompression sickness, free air in the abdomen). Intracranial hypertension. Acute intestinal obstruction. Facial trauma in the area where the mask is positioned on the face.
After an intraocular gas injection (SF6, C3F8) because of the risk of further expansion of the gas bubble with the potential to cause blindness. In patients with diagnosed but untreated vitamin B12 or folic acid deficiency (including in early pregnancy) or diagnosed genetic disorder of the enzyme system involved in metabolism of these vitamins.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Nitrous oxide should only be administered where there is adequate equipment available to secure an open airway immediately and commence emergency cardiopulmonary resuscitation if necessary. Administration must be undertaken by appropriately trained staff in well- ventilated areas, utilising gas scavenging and a double mask, for example.
The use of a double nose mask is recommended for dental surgery. In ambulances, the administration equipment may be connected to an exhaust system or a double mask and a chin mask may be used. The current occupational guidelines and legislation for the administration of nitrous oxide, particularly in relation to pregnant staff, must be observed.
When nitrous oxide is used outside an operating theatre there is an increased risk of loss of consciousness and coma. In such situations, the administration of nitrous oxide as an analgesic is therefore only acceptable in equimolar combination with 50% oxygen.
The equipment used must make it impossible to give mixtures containing over 50% nitrous oxide. 4).
However, in patients with undiagnosed subclinical deficiency of vitamin B12, neurological toxicity has occurred after a single exposure to Nitrous oxide for anaesthesia. Temperature effects: malignant hypothermia and hyperthermia.
Eye disorders:
Reduction of the speed gain of eye movement. Transient increase in pressure and/or volume of the eye after injection with gas-producing medicinal products.
Ear and labyrinth disorders:
Middle ear damage and ear drum rupture.
Cardiac disorders:
Nitrous oxide may cause arrhythmia, heart failure, pulmonary hypertension and systemic hypotension.
Respiratory, thoracic and mediastinal disorders:
Apnoea, pneumomediastinum, subcutaneous emphysema and symptoms comparable to reversible bronchiolitis. Diffusion hypoxia lasting for several minutes after cessation of the administration of nitrous oxide. There is no evidence that nitrous oxide causes hypoxaemia or increased mucus production.
Gastrointestinal disorders:
Nausea and vomiting (very common). Transient increase in pressure and/or volume in the intestines and abdominal cavity.
Hepatobiliary disorders:
Jaundice and increased concentration of hepatic enzymes. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
megaloblastic marrow changes, myeloneuropathy and subacute combined degeneration of the spinal cord) from the inhibitory effects on the methionine synthase. Nitrous oxide causes inactivation of vitamin B12, which is a co-factor of methionine synthase.
Folate metabolism is consequently interfered with and DNA synthesis is impaired following prolonged administration of nitrous oxide. Prolonged or frequent use of nitrous oxide may result in megaloblastic marrow changes, myeloneuropathy and subacute combined degeneration of the spinal cord.
Nitrous oxide should not be used without close clinical supervision and haematological monitoring. Specialist advice should be sought from a haematologist in such cases. Haematological assessment should include assessment for megaloblastic change in red cells and hypersegmentation of neutrophils.
Neurological toxicity can occur without anaemia or macrocytosis and with vitamin B12 levels in the normal range. In patients with undiagnosed subclinical deficiency of vitamin B12, neurological toxicity has occurred after single exposures to nitrous oxide during anaesthesia.
Monitoring of megaloblastic anemia and hypersegmentation of neutrophils is recommended in patient in poor nutritious condition and poor health. Nitrous oxide exerts synergistic effects on folate metabolism when administered with methotrexate (MTX), and this may impair tolerability to MTX.
Alternative treatment options for nitrous oxide may be considered in patients using MTX. 3). Administration of nitrous oxide should be undertaken with particular caution in the following situations: • Administration of nitrous oxide may increase the pressure in the balloon of a tracheal tube.
g. after cardiac surgery) in order to avoid the risk of further deterioration in heart function. • Hypovolaemic patients as a result of shock or heart failure (severe hypotension). • Patients with pernicious anaemia, Crohn’s disease or vegetarians.
• Patients being treated with bleomycin because the increased oxygen concentration during the inhalation sedation technique involves an increased risk of pulmonary toxicity. • Sickle cell anaemia. • During childbirth, where co-administration of nitrous oxide and opiates is not recommended because it could cause loss of consciousness.
• After intraocular injection, sufficient time must have passed in order to avoid the risk of visual problems. • Concomitant use of benzodiazepines for anxiety relating to dental procedures because this could cause loss of consciousness.
• Especially during sevoflurane anesthesia in patients with reduced autoregulatory reserve and during neurosurgical interventions, an increase in cerebral blood flow and reduction in blood pressure, ventilation, and heart rate may occur.
Nitrous oxide is a colourless gas with a slightly sweet odour; it is neither toxic nor flammable but will feed a fire; it is heavier than air and will accumulate in lower-lying locations. When using nitrous oxide, some of the gas will find its way into the ambient air as it is exhaled by the patient.
The use of double-seal face masks and sufficiently high ventilation rates (20x/hour) should ensure that the mean concentration remains below the set MAC value (maximal allowable concentration: 50 ppm or 152 mg/m³). Cases of reduced fertility and congenital defects in medical and paramedical staff have been reported after repeated exposure to nitrous oxide in poorly ventilated areas.
Peak exposure of pregnant women in the second and third months after their last menstruation has been held particularly responsible for this. If peak exposures during this period cannot be avoided, these […]