Fentanyl

The Basics

What is Fentanyl?

Used to relieve severe pain during and after surgery. Often in an epidural

Brand names for Fentanyl

Sublimaze

How Fentanyl is classified

Analgesics – Opioid, Narcotics, Anesthetics – Intravenous, Opiates

Fentanyl During Pregnancy

Fentanyl pregnancy category

Category CNote 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 Fentanyl while pregnant

Some studies suggest that opioids as a general group might be associated with birth defects including heart defects and cleft lip and palate. However, these and other studies have not found a specific pattern of birth defects caused by opioids. Based on available studies, if there is an increased chance for birth defects with opioid use in pregnancy, it is likely to be small. Studies have reported a risk for neonatal abstinence syndrome (NAS) with some opioid medicines; however, not all medications have been studied. Based on what we know about the risk of NAS with other opioids, it is likely that fentanyl also has a risk for NAS. Because there are few studies, we do not know if the risk is higher or lower than with other opioids.*

Taking Fentanyl While Breastfeeding

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

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of fentanyl ingested by the neonate are usually small and are not expected to cause any adverse effects in breastfed infants. The results of studies on the effect of epidural fentanyl on breastfeeding initiation and duration are mixed and controversial, because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used and deficient designs of many of the studies. In infants placed skin-to-skin after a normal vaginal delivery, epidural fentanyl given during labor may delay the infant’s first suckling in a dose-dependent manner,[1] perhaps because it can persist in the infant’s serum for over 24 hours after discontinuation.[2] However, it appears that with good breastfeeding support, epidural fentanyl plus bupivacaine has little overall effect on breastfeeding success.[3][4][5][6][7] No waiting period or discarding of milk is required before resuming breastfeeding after fentanyl is used for short procedures (e.g., for endoscopy).[8][9] After general anesthesia, breastfeeding can be resumed as soon as the mother has recovered sufficiently from anesthesia to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure. Limited information indicates that transdermal fentanyl in a dosage of 100 mcg/hour results in undetectable fentanyl concentrations in breastmilk. 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 fentanyl to a few days at a low dosage with close infant monitoring. 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

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of fentanyl ingested by the neonate are usually small and are not expected to cause any adverse effects in breastfed infants. The results of studies on the effect of epidural fentanyl on breastfeeding initiation and duration are mixed and controversial, because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used and deficient designs of many of the studies. In infants placed skin-to-skin after a normal vaginal delivery, epidural fentanyl given during labor may delay the infant’s first suckling in a dose-dependent manner,[1] perhaps because it can persist in the infant’s serum for over 24 hours after discontinuation.[2] However, it appears that with good breastfeeding support, epidural fentanyl plus bupivacaine has little overall effect on breastfeeding success.[3][4][5][6][7] No waiting period or discarding of milk is required before resuming breastfeeding after fentanyl is used for short procedures (e.g., for endoscopy).[8][9] After general anesthesia, breastfeeding can be resumed as soon as the mother has recovered sufficiently from anesthesia to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure. Limited information indicates that transdermal fentanyl in a dosage of 100 mcg/hour results in undetectable fentanyl concentrations in breastmilk. 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 fentanyl to a few days at a low dosage with close infant monitoring. 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 Fentanyl on milk supply

Fentanyl can increase serum prolactin.[20][21] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

In 58 breastfeeding mothers who received an epidural fentanyl dosage greater than 150 mcg during labor, 21% reported more difficulty in establishing breastfeeding at 24 hours after delivery compared to 10% of mothers who received to a lower dosage or to no fentanyl. There was no difference in breastfeeding difficulty noted between the groups 24 hours after delivery when the assessment was performed by a lactation consultant. Women in the high-dose group who could be contacted were more likely to discontinue breastfeeding by 6 weeks after delivery and there was a higher rate of breastfeeding discontinuation at 6 weeks among mothers who reported breastfeeding difficulty 24 hours after delivery.[17] A relatively high dropout rate from the study at 6 weeks clouds the results.[18]

A retrospective study of a random sample of 425 mothers delivering in a maternity unit found a dose-related increased risk of bottle feeding at hospital discharge associated with fentanyl administered during labor.[22]

A prospective cohort study compared women who received continuous epidural analgesia with fentanyl and either bupivacaine or ropivacaine during labor and delivery (n = 52) to women who received no analgesia (n = 63). The average total fentanyl dosage was 124 mcg and the average total infusion time from start to delivery was 219 minutes. The study found no differences between the groups in breastfeeding effectiveness or infant neurobehavioral status at 8 to 12 hours postpartum or the number exclusively or partially breastfeeding at 4 weeks postpartum.[23]

A randomized, prospective study measured infant breastfeeding behavior following epidural or intravenous fentanyl during delivery in 100 multiparous mothers undergoing cesarean section and delivering fullterm, healthy infants. Epidural fentanyl was given to 50 women in a dose of 100 to 150 mcg in divided doses followed by a continuous epidural infusion of 20 mcg/hour. Intravenous fentanyl was given to 50 women as a single dose of 50 mcg after delivery. Both groups received epidural or spinal bupivacaine in addition. A slight difference was seen in breastfeeding behavior between the groups, with the infants in the intravenous fentanyl group performing slightly worse than those in the epidural group. However, all mothers were able to breastfeed their infants at 24 hours. None had severe breastfeeding problems; 10 women in the epidural group reported mild or moderate problems and 7 women in the intravenous group reported breastfeeding problems. Twenty mothers in the epidural group and 14 in the intravenous group used supplemental bottle feeding, with the difference not statistically significant.[14]

A randomized, multicenter trial compared the initiation rate and duration of breastfeeding in women who received high-dose epidural bupivacaine alone, or one of two low-dose combinations of bupivacaine plus fentanyl. The average fentanyl dosages in the two groups were 97 and 151 mcg in the first stage of labor and 10 and 12 mcg of fentanyl during the second stage of labor, respectively, with great variability. A nonepidural matched control group was also compared. No differences in breastfeeding initiation rates or duration were found among the epidural and nonmedicated groups, but women in the nonepidural group who received systemic meperidine had a lower breastfeeding initiation rate than in the other groups.[24]

A nonrandomized study in low-risk mother-infant pairs found that there was no difference overall in the amount of sucking by newborns, whether their mothers received bupivacaine plus fentanyl, or fentanyl alone by epidural infusion in various dosages, or received no analgesia for childbirth. In a subanalysis by sex and number of sucks, female infants were affected by high-dose bupivacaine and high-dose fentanyl, but male infant were not.[25] However, the imbalances of many factors between the study groups makes this study difficult to interpret.

In a prospective cohort study, 87 multiparous women who received epidural bupivacaine and fentanyl for pain control during labor and vaginal delivery. A loading dose of 0.125% bupivacaine with fentanyl 50-100 mcg. Epidural analgesia is maintained using 0.0625% bupivacaine and fentanyl 0.2 mcg/mL. The median dose of fentanyl received by the women was 151 mcg (range 30 to 570 mcg). The women completed questionnaires at 1 and 6 weeks postpartum regarding breastfeeding. Most women had prior experience with breastfeeding, support at home and ample time off from work. All women were breastfeeding at 1 week postpartum and 95.4% of women were breastfeeding at 6 weeks postpartum.[26]

A nonrandomized study at one Italian hospital compared primaparous mothers undergoing vaginal delivery who received epidural analgesia (n = 64) to those who did not (n = 64). Mothers who requested the epidural analgesia received an initial dose of 100 mcg of fentanyl diluted to 10 mL with saline. After the initial fentanyl, doses of 15 to 20 mL of 0.1% ropivacaine were administered if needed. The only difference between the groups of mothers was a longer duration of labor among the treated mothers. The quality of infant nursing was equal between the 2 groups of infants on several measures; however, more infants in the treated group breastfed for less than 30 minutes at the first feeding.[27]

A national survey of women and their infants from late pregnancy through 12 months postpartum compared the time of lactogenesis II in mothers who did and did not receive pain medication during labor. Categories of medication were spinal or epidural only, spinal or epidural plus another medication, and other pain medication only. Women who received medications from any of the categories had about twice the risk of having delayed lactogenesis II (>72 hours) compared to women who received no labor pain medication.[28]

A randomized study compared the effects of cesarean section using general anesthesia, spinal anesthesia, or epidural anesthesia, to normal vaginal delivery on serum prolactin and oxytocin as well as time to initiation of lactation. General anesthesia was performed using propofol 2 mg/kg and rocuronium 0.6 mg/kg for induction, followed by sevoflurane and rocuronium 0.15 mg/kg as needed. After delivery, patients in all groups received an infusion of oxytocin 30 international units in 1 L of saline, and 0.2 mg of methylergonovine if they were not hypertensive. Fentanyl 1 to 1.5 mcg/kg was administered after delivery to the general anesthesia group. Patients in the general anesthesia group (n = 21) had higher post-procedure prolactin levels and a longer mean time to lactation initiation (25 hours) than in the other groups (10.8 to 11.8 hours). Postpartum oxytocin levels in the nonmedicated vaginal delivery group were higher than in the general and spinal anesthesia groups.[29]

A randomized, nonblinded study compared the use of intramuscular meperidine 100 mg to intranasal (mean dose 486 mcg) or subcutaneous (mean dose 300 mcg) fentanyl for labor analgesia. More women in the meperidine group had difficulty establishing lactation (79%) than in the intranasal (39%) or subcutaneous (44%) fentanyl groups. Mothers who received meperidine reported more sedation, had longer labors, and their infants were more likely to be admitted to the nursery.[30][31]

A retrospective study in a Spanish public hospital compared the infants of mothers who received an epidural during labor that contained fentanyl and either bupivacaine or ropivacaine. Infants of mothers who received an epidural had a lower frequency of early breastfeeding.[32]

A small prospective study in California compared women who received an epidural infusion of fentanyl and ropivacaine to mothers who did not receive an epidermal during labor. All mothers had normal vaginal deliveries and their infants had 1 uninterrupted hour of skin-to-skin contact immediately postpartum. The study found inverse relationships between the amount of fentanyl and the amount of oxytocin received during labor and the time of the first suckling. Because women who received more fentanyl also tended to receive more oxytocin, the study could not clearly separate the effects of the two drugs.[1]

A randomized, double-blind study compared three epidural maintenance solutions for labor analgesia in women receiving epidural analgesia during labor: bupivacaine 1 mg/mL, bupivacaine 0.8 mg/mL with fentanyl 1 mcg/mL, or bupivacaine 0.625 mg/mL with fentanyl 2 mcg/mL. At 6 weeks postpartum, the breastfeeding rate was 94% or greater in all groups, with no difference among them. All mothers delivered full-term infants and were highly motivated to breastfeed and almost all had vaginal deliveries.[33]

A prospective cohort study in 1204 Israeli women on the effect of labor epidural analgesia during labor, the following protocol was used: bupivacaine 0.1% 15 mL and fentanyl 100 mcg in 5-mL increments, followed by an epidural infusion of bupivacaine 0.1% 10 mL and fentanyl 2 mcg/mL, with a patient-controlled epidural analgesia modality with 5 mL bolus with a lock-out time of 15 minutes. A 6 weeks postpartum, the breastfeeding and exclusive breastfeeding rates were lower (74% and 52%, respectively) in mothers who received the epidural analgesia than in those who did not (83% and 68%, respectively). However, the difference was mostly accounted for by parity, with the intervention having little effect on multiparous women.[34]

A prospective study in an Australian hospital compared mothers who received epidural fentanyl analgesia, subcutaneous morphine or neither during labor and delivery. When controlled for labor induction, instrumental delivery and special care nursery admission, no difference was seen between the 3 groups in breastfeeding rates at discharge or at 6 weeks postpartum.[35]

A randomized, partially blinded study in a hospital in Thailand compared intravenous meperidine and fentanyl for pain during active labor. Mothers received either meperidine 50 mg (n = 46) or fentanyl 50 mcg (n = 46) initially and then every 1 (fentanyl) or 2 (meperidine) hours as requested by the mother. The percentages of infants who breastfed in the first 24 hours were only 61% for meperidine and 54% for fentanyl, although the difference was not statistically significant. Care of the infants (e.g., skin-to-skin in the first hour) was not reported.[36]

Possible alternatives to Fentanyl

Acetaminophen, Butorphanol, Hydromorphone, Ibuprofen, Morphine.