Skip to main content

Table 3 Studies of pharmacologic treatment for neonatal abstinence syndrome

From: Review of the assessment and management of neonatal abstinence syndrome

Reference Design Purpose Comparison (Index vs. Reference) Assessment measure Primary outcome Results
Jackson, 2004[50] Double-blind RCT Efficacy of opioid vs. phenobarbitone as first-line therapy Morphine (n = 41) Phenobarbitone (n = 34) Lipsitz Mean length of Rx 8 vs. 12 days* (unadjusted)
Langenfeld, 2005[51] Randomized Trial, Blinding Not Specified Compare tincture of opium to oral morphine Morphine (n = 17) Finnegan Mean length of Rx 29.8 vs. 26.9 days
   Tincture of Opium (n = 16)   Mean LOS 37.5 vs. 32.4 days
Kraft, 2008[52] Phase I, Randomized, Open Label, Active Control Feasibility and safety of buprenorphine in Rx of NAS Buprenorphine (n = 13) Modified Finnegan Mean length of Rx 22 (SD 12) vs. 32 (SD 16) days
   Neonatal opium solution (n = 13)   Mean LOS 27 (SD 11) vs. 38 (SD 13) days
Kraft, 2011[53] Phase I, Randomized, Open Label, Active Control Feasibility and safety of buprenorphine Buprenorphine (n = 12) Modified Finnegan Mean length of Rx 23 vs. 38 days*
   Morphine (n = 12)   Mean LOS 23 vs. 42 days
Coyle, 2002[54] Partially Randomized, Controlled Trial Assess whether Rx with DTO + phenobarbital vs. DTO alone is better DTO + phenobarbital (n = 10) Finnegan Finnegan Scores Infants in placebo group, spent more time with FS > 7 *
   DTO + placebo (n = 10)    Infants in phenobarbital group spent more time with FS < 5*
     Mean LOS Mean: 38 vs. 79 days*
Agthe, 2009[55] Randomized, Double-Blinded Controlled Trial To assess use of clonidine as an adjunct therapy to opioids to manage NAS Clonidine (n = 40) Modified Finnegan Mean length of Rx 11 (95% CI 8–15) vs. 15 (95% CI 12–17) days
   Placebo (n = 40)    
Surran, 2013[56] Randomized, Nonblinded Controlled Trial Clonidine versus phenobarbital to reduce # days of Rx with morphine sulfate Phenobarbital (n = 34) Modified Finnegan Length of Rx with morphine sulfate B = -4.6 days (95% CI 0.3–8.9)*
   Clonidine (n = 32)    
  1. Abbreviations: NAS Neonatal Abstinence Syndrome, Rx Treatment, # Number, LOS Length of Hospital Stay, DTO Diluted Tincture of Opium.
  2. *indicated p < 0.05.