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Sufentanil

Last Revision: October 19, 2020.

Estimated reading time: 4 minutes

CASRN: 56030-54-7

image 135003073 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of sufentanil ingested by the neonate are small and would not be expected to cause any adverse effects in breastfed infants. Labor pain medication may delay the onset of lactation; however, it appears that with good breastfeeding support, epidural sufentanil plus a local anesthetic has little or no effect on breastfeeding success.[1,2]

Because of sufentanil's long half-life during continued intravenous infusion or repeated intravenous administration,[1] sufentanil levels in milk would be expected to increase if used for an extended period postpartum. Once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of sufentanil to a few days. Because there is no published experience with repeated doses of intravenous or sublingual sufentanil during established lactation, other agents may be preferred, especially while nursing a newborn or preterm infant. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Drug Levels

Sufentanil is metabolized to a minimally active and inactive metabolites. The oral bioavailability of sufentanil is unknown. Therapeutic plasma levels from intravenous sufentanil during surgery in adults are 0.25 to 8 mcg/L. The usual intravenous dosage of sufentanil for anaesthesia in an infant during surgery is 10 to 15 mcg/kg. Lower dosages 0.25 to 1 mcg/kg are used for analgesia. Sufentanil is also commonly administered epidurally. Plasma levels are markedly lower when the epidural route is used.[3]

Maternal Levels. Nine women who had undergone cesarean section received sufentanil 50 mcg epidurally immediately after delivery. Sufentanil was undetectable (<0.1 mcg/L) in colostrum at about 1 hour after the dose.[4]

Twenty-nine women undergoing cesarean section received 20 mcg of epidural sufentanil prior to surgery and were then randomized to receive either an epidural anaesthetic combined with sufentanil 3.75 mcg per hour plus 1.25 mcg every 20 minutes as needed via a patient-controlled epidural analgesia (PCEA) device, or an epidural anaesthetic alone via PCEA with no sufentanil. Breastmilk was sampled on postpartum days 1, 2 and 3. Sufentanil was detected in breastmilk in all groups. Levels were highest in the group receiving postpartum sufentanil via PCEA; however, cumulative sufentanil dosages were not reported. Milk levels were apparently low in the other 2 groups.[5] Reporting errors in this study do not allow for estimation of infant sufentanil dose from milk.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Newborns of breastfeeding mothers who received epidural sufentanil before and after cesarean section delivery were reportedly not clinically affected and had no differences in behavior or clinical signs over 3 days postpartum compared to newborns of mothers who received epidural sufentanil prior to delivery only.[5]

Effects on Lactation and Breastmilk

Narcotics can increase serum prolactin.[6,7] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

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.[8]

A nonrandomized convenience sample of women who did (n = 209) or did not (n = 157) receive epidural analgesia during labor was analyzed to determine whether epidurals affected the onset of lactation. Although not standardized, the typical procedure used sufentanil 10 to 15 mg together with either ropivacaine 0.1% or levobupivacaine 0.0625% epidurally, supplemented by epidural boluses of ropivacaine 0.1% or levobupivacaine 0.0625% about every 2 hours. No difference was found in the time of lactation onset between the two groups. Although women in both groups stated they wished to breastfeed prior to delivery, exclusive breastfeeding at 20 days postpartum was less frequent in the women who received an epidural (43%) than in women who did not (57%).[9]

In a study in China, women with a scheduled cesarean section were randomized to receive intravenous patient-controlled analgesia with either sufentanil or tramadol. Postpartum prolactin levels were higher in the tramadol group (348 mcg/L) than in the sufentanil group (314 mcg/L). The onset of lactation was sooner in the tramadol group (21.4 hours) than in the sufentanil group (25.1 hours). Both of these difference were statistically significant.[10] Note that injectable tramadol is not available in the U.S.

A study of 169 pregnant women randomized them to receive one of three solutions as epidural anesthesia during labor. Bupivicaine 0.1% or 0.125% was combined with sufentanil 5 mcg and bupivacaine 0.1% was combined with sufentanil 10 mcg, each in 15 mL. No difference in average LATCH score was found among the infants in the 3 groups.[11]

A retrospective medical record study in China compared women who received patient-controlled epidural analgesia during labor (n = 527) to those who did not (n = 395). Epidural analgesia included 0.1% levobupivacaine and 5 mg of sufentanil in 10 mL of saline. All women completed a questionnaire regarding their breastfeeding experience at 6 months postpartum. There were no statistically significant differences between the groups in the proportion who initiated breastfeeding within 1 hour after birth or who exclusively or partially breastfed their infants at 1, 3, or 6 months postpartum.[12]

References

1.
Zuppa AA, Alighieri G, Riccardi R, et al. Epidural analgesia, neonatal care and breastfeeding. Ital J Pediatr. 2014;40:82. [PMC free article: PMC4335561] [PubMed: 25432659]
2.
French CA, Cong X, Chung KS. Labor epidural analgesia and breastfeeding: A systematic review. J Hum Lact. 2016;32:507–20. [PubMed: 27121239]
3.
Hansdóttir V, Woestenborghs R, Nordberg G. The pharmacokinetics of continuous epidural sufentanil and bupivacaine infusion after thoracotomy. Anesth Analg. 1996;83:401–6. [PubMed: 8694326]
4.
Madej TH, Strunin L. Comparison of epidural fentanyl with sufentanil. Anaesthesia. 1987;42:1156–61. [PubMed: 2963561]
5.
Cuypers L, Wiebalck A, Vertommen JD, et al. Epidural sufentanil for postcesarean pain: breast milk levels and effects on the baby. Acta Aneasthiol Belg. 1995;46:104–5.
6.
Tolis G, Dent R, Guyda H. Opiates, prolactin, and the dopamine receptor. J Clin Endocrinol Metab. 1978;47:200–3. [PubMed: 263291]
7.
Frecska E, Perenyi A, Arato M. Blunted prolactin response to fentanyl in depression. Normalizing effect of partial sleep deprivation. Psychiatry Res. 2003;118:155–64. [PubMed: 12798980]
8.
Lind JN, Perrine CG, Li R. Relationship between use of labor pain medications and delayed onset of lactation. J Hum Lact. 2014;30:167–73. [PMC free article: PMC4684175] [PubMed: 24451212]
9.
Mauri PA, Contini NN, Giliberti S, et al. Intrapartum epidural analgesia and onset of lactation: A prospective study in an Italian birth centre. Matern Child Health J. 2015;19:511–8. [PubMed: 24894732]
10.
Chi X, Li M, Mei W, et al. Comparison of patient-controlled intravenous analgesia with sufentanil versus tramadol in post-cesarean section pain management and lactation after general anesthesia - a prospective, randomized, double-blind, controlled study. J Pain Res. 2017;10:1521–7. [PMC free article: PMC5505163] [PubMed: 28740418]
11.
Wang T, Lu Y, Zhou P, et al. A randomized controlled comparison of epidural analgesia onset time and adverse reactions during labor with different dose combinations of bupivacaine and sufentanil. Clin J Pain. 2020;36:612–7. [PubMed: 32349005]
12.
Xu Q, Wu ZF, Yang NN, et al. Impact of epidural analgesia during labor on breastfeeding initiation and continuation: A retrospective study. J Matern Fetal Neonatal Med. 2020;33:3816–9. [PubMed: 30890010]

Substance Identification

Substance Name

Sufentanil

CAS Registry Number

56030-54-7

Drug Class

Breast Feeding

Lactation

Analgesics, Opioid

Narcotics

Anesthetics, Intravenous

Opiates

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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