Gary Peltz1, Lauren M Jansson2, Susan Adeniyi-Jones3, Carol Cohane4, David Drover4, Steven Shafer4, Meiyue Wang4, Manhong Wu4, Balaji Govindaswami5, Priya Jegatheesan5, Cynthia Argani6, Salwa Khan7, Walter K Kraft8. 1. Department of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA. gpeltz@stanford.edu. 2. Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 3. Department of Pediatrics Nemours Neonatology at Jefferson, Thomas Jefferson University, Philadelphia, PA, USA. 4. Department of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA. 5. Department of Pediatrics, Santa Clara Valley Medical Center, San Jose, CA, USA. 6. Department of Obstetrics and Gynecology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 7. Division of Hospital Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 8. Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA.
Abstract
OBJECTIVE: To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS). STUDY DESIGN: A multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days. RESULTS: Twenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment. CONCLUSIONS: Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT01965704.
OBJECTIVE: To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS). STUDY DESIGN: A multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days. RESULTS: Twenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment. CONCLUSIONS: Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT01965704.