The pharmacokinetics and physiological effects of buprenorphine infusion in premature neonates.

Abstract

1. The pharmacokinetics and physiological effects of buprenorphine were studied in 12 newborn premature neonates (27 to 32 weeks gestational age) who were given a loading dose of 3.0 micrograms kg‐1 of buprenorphine followed by an intravenous infusion of 0.72 micrograms kg‐ 1 h‐1 of buprenorphine. Plasma concentrations of buprenorphine were measured during the infusion, at steady‐state and for 24 h after the cessation of the buprenorphine infusion. 2. The mean steady‐state plasma buprenorphine concentration (+/‐ s.d.) for an infusion rate of 0.72 micrograms kg‐1 h‐1 was 4.3 +/‐ 2.6 ng ml‐1. 3. Buprenorphine clearance was 0.23 +/‐ 0.07 l h‐1 kg‐1, the elimination half‐life was 20 +/‐ 8 h and the volume of distribution was 6.2 +/‐ 2.11 l kg‐1. 4. Small but significant falls were noted in systolic blood pressure at 6 h and heart rate at 1, 6 and 12 h after the administration of buprenorphine, but these did not appear to cause any clinical deterioration. 5. Four of the 12 subjects studied required an increase in the infusion rate of buprenorphine to achieve adequate sedation. 6. The results suggest that this dosing regimen of buprenorphine is safe but may not be as effective as other opioids in producing sedation and analgesia in premature newborns.

Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome

“…Also, since we excluded preterm infants and those with in utero exposure to benzodiazepines, our results should not be generalized to infants with such characteristics. Buprenorphine has been used in critically ill preterm infants, 15 but its utility in preterm infants with the neonatal abstinence syndrome has not been defined. Preterm infants have a decreased incidence and severity of withdrawal signs, 16–18 and it is unclear whether the standard scoring instruments that we used would be valid in this population.…”

Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome

“…Also, since we excluded preterm infants and those with in utero exposure to benzodiazepines, our results should not be generalized to infants with such characteristics. Buprenorphine has been used in critically ill preterm infants, 15 but its utility in preterm infants with the neonatal abstinence syndrome has not been defined. Preterm infants have a decreased incidence and severity of withdrawal signs, [16][17][18] and it is unclear whether the standard scoring instruments that we used would be valid in this population.…”

Buprenorphine Substitution Ameliorates Spontaneous Withdrawal in Fentanyl-Dependent Rat Pups

“…Buprenorphine is commercially available, and its pharmacokinetic and pharmacologic effects i.v. have been characterized in human neonates (49). Hopefully further research and clinical trials will be stimulated by these results.…”