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Opioid Analgesic (Short-Acting — Perioperative) Pregnancy: No adequate data in pregnant women; fentanyl can cross the placenta in early pregnancy and animal studies have shown some reproductive toxicity. Regular use during pregnancy may cause drug dependence in the foetus leading to neonatal withdrawal. Administration during labour may depress respiration in the neonate - an antidote for the child should be readily available. Administration to nursing women is not recommended; breast-feeding or use of expressed milk is not recommended within 24 hours of treatment.

Fentanyl (Perioperative Analgesia)

Brand names: Sublimaze (IV), Durogesic (patch)

Fentanyl is a potent short-acting synthetic opioid used perioperatively for analgesia and to blunt the stress response at induction and during surgery.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Spontaneous respiration: initial 50-200 micrograms, supplemental 50 micrograms. Assisted ventilation: initial 300-3500 micrograms, supplemental 100-200 micrograms.
Route: Intravenous, either as a bolus or by infusion; intramuscular. Give only in an environment where the airway can be controlled and by personnel who can control the airway.
Frequency: Initial dose at induction with supplemental doses as required during anaesthesia; dose individualised to age, body weight, physical status, underlying condition, other drugs and type of surgery and anaesthesia.
Adult dose table quoted verbatim from the SPC (Fentanyl 50 microgram/ml Injection, section 4.2): Spontaneous Respiration - initial 50-200 micrograms, supplemental 50 micrograms; Assisted Ventilation - initial 300-3500 micrograms, supplemental 100-200 micrograms. 'Doses in excess of 200 micrograms are for use in anaesthesia only.' UNITS ARE MICROGRAMS throughout - do not read as mg. Premedication: 1-2 ml fentanyl (i.e. of the 50 microgram/ml injection) may be given intramuscularly 45 minutes before induction of anaesthesia. Expected effect after IV administration in unpremedicated adults: 2 ml provides sufficient analgesia for 10-20 minutes in low pain intensity surgical procedures; 10 ml injected as a bolus gives analgesia lasting about one hour, sufficient for moderately painful procedures; 50 micrograms/kg provides intense analgesia for some four to six hours for intensely stimulating surgery. INFUSION (exact units as stated in the SPC): in ventilated patients a loading dose may be given as a fast infusion of approximately 1 microgram/kg/min for the first 10 minutes, followed by an infusion of approximately 0.1 micrograms/kg/min; alternatively the loading dose may be given as a bolus. Infusion rates should be titrated to individual patient response and lower rates may be adequate. Lower infusion rates, e.g. 0.05-0.08 micrograms/kg/minute, are necessary if spontaneous ventilation is to be maintained. Higher infusion rates (up to 3 micrograms/kg/minute) have been used in cardiac surgery. Unless post-operative ventilation is planned, the infusion should be terminated at about 40 minutes before the end of surgery. To avoid bradycardia it is recommended to give a small intravenous dose of an anticholinergic just before anaesthetic induction. Obese patients: risk of overdosing if the dose is calculated on body weight - calculate dosage according to estimated lean body mass. Elderly (over 65 years) and debilitated patients: reduce the initial dose and take its effect into account when determining supplemental doses. Fentanyl is chemically incompatible with pentobarbital sodium, thiopentone and methohexitone. Discuss a strategy for ending opioid treatment before starting, to minimise the risk of addiction and drug withdrawal syndrome. NOTE: the fetched SPC section 4.4 was truncated at the source-fetch limit; section 4.5 was not fetched.

Paediatric dose

Route: Intravenous
Frequency: Initial dose at induction, with supplemental doses of 1-1.25 micrograms/kg as required
Max: Not stated in the fetched SPC text
SPC dose table for children aged 2 to 11 years: initial 1-3 micrograms/kg and supplemental 1-1.25 micrograms/kg, for BOTH spontaneous respiration and assisted ventilation. Children aged 12 to 17 years: follow adult dosage. UNITS ARE MICROGRAMS/kg - a single dosePerKg value is not given because the SPC states a range (1-3 micrograms/kg), so dosePerKg is deliberately left null. Techniques involving analgesia in a spontaneously breathing child should only be used as part of an anaesthetic technique, or as part of a sedation/analgesia technique with experienced personnel in an environment that can manage sudden chest wall rigidity requiring intubation, or apnoea requiring airway support. Verify against a children's formulary before use.

Dose adjustments

Renal

In patients with renal impairment reduced dosing of fentanyl should be considered, and these patients should be observed carefully for signs of fentanyl toxicity.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to any of the excipients, or to other opioids
  • Respiratory depression, obstructive airways disease
  • Concurrent administration with monoamine oxidase inhibitors or within 2 weeks of their discontinuation

Side effects

  • Nausea (26.1%) and vomiting (18.6%) - very common
  • Muscle rigidity, which may also involve the thoracic muscles (10.4%) - very common
  • Hypotension (8.8%) and hypertension (8.8%); bradycardia (6.1%), tachycardia, arrhythmia
  • Sedation (5.3%), dyskinesia, dizziness; postoperative confusion; delirium (not known)
  • Respiratory: laryngospasm, bronchospasm, apnoea (uncommon); respiratory depression (not known); airway complication of anaesthesia
  • Hypersensitivity including anaphylactic shock, anaphylactic reaction and urticaria; drug dependence and drug withdrawal syndrome

Interactions

  • Monoamine oxidase inhibitors - concurrent administration, or administration within 2 weeks of their discontinuation, is contraindicated (SPC section 4.3)
  • CYP3A4 inhibitors (e.g. macrolide antibiotics such as erythromycin, azole antifungals such as ketoconazole, protease inhibitors) - can increase fentanyl plasma concentration causing increased or prolonged opioid effects; consider dose reduction and monitor frequently for respiratory depression and sedation (US FDA label; UK SPC section 4.5 was not in the fetched bundle)
  • Chemically incompatible in solution with pentobarbital sodium, thiopentone and methohexitone (SPC section 6.2)

Clinical monograph

How it works

It is a strong mu-opioid receptor agonist, producing rapid-onset analgesia and dose-dependent respiratory depression.

Prescribing in practice

  • It causes dose-dependent respiratory depression that may outlast its analgesic effect and can recur, so titrate carefully, ensure airway and ventilatory support, and have naloxone available.
  • Rapid or high-dose administration can cause bradycardia and chest-wall (truncal) rigidity impairing ventilation.
  • Effects are potentiated by other CNS depressants and benzodiazepines, increasing the risk of profound sedation.

Monitoring

Monitor respiratory rate, oxygen saturation, sedation level and haemodynamics during and after administration.

Counselling the patient

  • You may feel very drowsy and your breathing will be monitored closely.
  • Report any breathing difficulty or excessive sleepiness in recovery.

Evidence & guidelines

Perioperative use is established through its licensed anaesthetic indications and long-standing clinical practice.

Reference: RCoA Acute Pain Handbook; ANZCA Opioid Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.