Remifentanil should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, and by persons specifically trained in the use of anaesthetic medicinal products and the recognition and management of the expected undesirable effects of potent opioids, including respiratory and cardiac resuscitation.
Such training must include the establishment and maintenance of a patent airway and assisted ventilation. The use of remifentanil in mechanically ventilated intensive care patients is not recommended for a duration of treatment greater than 3 days.
Patients with a known hypersensitivity to opioids of a different class may exhibit a hypersensitivity reaction following administration of remifentanil. Caution should be exercised before using remifentanil in these patients. Remifentanil should not be used as an analgesic in procedures where patients remain conscious or do not receive any airway support during the procedure.
Rapid offset of action/transition to alternative analgesia Due to the very rapid offset of action of remifentanil, patients may emerge rapidly from anaesthesia and no residual opioid activity will be present within 5-10 minutes after the discontinuation of remifentanil.
For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil. During administration of remifentanil as a μ-opioid agonist the potential for the development of tolerance, hyperalgesia and associated haemodynamic changes should be considered.
Therefore, prior to discontinuation of remifentanil, patients must be given alternative analgesic and sedative medicinal products at a sufficient time in advance to allow the therapeutic effects of these medicinal products to become established and to prevent hyperalgesia and concomitant haemodynamic changes.
For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil. Sufficient time must be allowed to reach the maximum effect of the longer acting analgesic.
The choice of analgesic should be appropriate for the patient's surgical procedure and the level of post-operative care. When other opioid medicinal products are administered as part of the regimen for transition to alternative analgesia, the benefit of providing adequate post-operative analgesia must always be balanced against the potential risk of respiratory depression with these medicinal products.
Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of Remifentanil and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Remifentanil concomitantly with sedative medicinal products, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids.
Abuse or intentional misuse of opioids may result in overdose and/or death. g. major depression, anxiety and personality disorders). Discontinuation of treatment and withdrawal syndrome Repeated administration at short term intervals for prolonged periods may result in the development of withdrawal syndrome after cessation of therapy.
Symptoms following withdrawal of remifentanil including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days. Where reported, re-introduction and tapering of the infusion has been beneficial.
The use of remifentanil in mechanically ventilated intensive care patients is not recommended for duration of treatment greater than 3 days. Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with remifentanil.
To minimise symptoms of withdrawal tapering from a high dose may take weeks to months. Additional to the symptoms mentioned above the opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, or increased respiratory rate. Muscle rigidity - prevention and management At the doses recommended muscle rigidity may occur.
The incidence of muscle rigidity is related to the dose and rate of administration. Therefore, bolus injections should be administered over not less than 30 seconds. Muscle rigidity induced by remifentanil must be treated in the context of the patient's clinical condition with appropriate supporting measures including ventilatory support.
Excessive muscle rigidity occurring during the induction of anaesthesia should be treated by the administration of a neuromuscular blocking […]