Remifentanil

The Basics

What is Remifentanil?

A potent, short-acting synthetic opioid analgesic drug given to patients during surgery to relieve pain and as an adjunct to an anaesthetic.

Brand names for Remifentanil

Ultiva

How Remifentanil is classified

Analgesics – Opioid, Narcotics, Anesthetics – Intravenous, Opiates

Remifentanil During Pregnancy

Remifentanil pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Remifentanil while pregnant

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced fetal rat body weight and pup weights were reported at 2.2 times a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours. There were no malformations noted when remifentanil was administered via bolus injection to pregnant rats or rabbits during organogenesis at doses approximately 5 times and approximately equal, respectively, to a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours .The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Taking Remifentanil While Breastfeeding

What are recommendations for lactation if you're taking Remifentanil?

Because the half-life of remifentanil is extremely short, it is unlikely to cause any adverse effects in the breastfed newborn if it is given to the mother for labor analgesia or a surgical procedure. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. Once the mother’s milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of remifentanil to a few days. However, because no information is available on the use of remifentanil during breastfeeding, an alternate drug may be preferred if the mother requires prolonged administration of remifentanil during the early postpartum period. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Maternal / infant drug levels

Because the half-life of remifentanil is extremely short, it is unlikely to cause any adverse effects in the breastfed newborn if it is given to the mother for labor analgesia or a surgical procedure. Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. Once the mother’s milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of remifentanil to a few days. However, because no information is available on the use of remifentanil during breastfeeding, an alternate drug may be preferred if the mother requires prolonged administration of remifentanil during the early postpartum period. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Possible effects of Remifentanil on milk supply

Narcotics can increase serum prolactin.[2][3] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

A double-blind, randomized study compared patient-controlled intravenous (IV) analgesia with remifentanil (n = 43) to a continuous meperidine infusion (n = 45) for labor analgesia. Patients receiving remifentanil used an average total dosage of 1035 mcg/kg and those receiving meperidine received an average total dosage of 150 mg/kg. Breastfeeding difficulties were experienced in 6.3% of the infants of mothers who received remifentanil and 12.8% of infants whose mothers received meperidine; however, this difference was not statistically significant.[4]

Possible alternatives to Remifentanil

Acetaminophen, Butorphanol, Fentanyl, Hydromorphone, Ibuprofen, Morphine.