Article

Clonidine as an Adjunct Therapy to Opioids for Neonatal Abstinence Syndrome: A Randomized, Controlled Trial

Department of Pediatrics, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
PEDIATRICS (Impact Factor: 5.3). 05/2009; 123(5):e849-56. DOI: 10.1542/peds.2008-0978
Source: PubMed

ABSTRACT To determine if oral clonidine would reduce the duration of opioid detoxification for neonatal abstinence syndrome.
Infants with intrauterine exposure to methadone or heroin and neonatal abstinence syndrome (2 consecutive modified Finnegan scores of > or =9) were enrolled at 2 hospitals during 2002-2005 and followed until final hospital discharge. All enrolled infants (80) received oral diluted tincture of opium according to a standardized algorithm and were randomly assigned to receive oral clonidine (1 microg/kg every 4 hours) (40 infants) or placebo (40 infants). Primary outcome was duration of opioid therapy. Secondary outcomes included the amount of opium required to control symptoms, number of treatment failures, and differences in blood pressure, heart rate, and oxygen saturation.
The median length of therapy was 27% shorter in the clonidine group (11 [95% confidence interval: 8-15 days]) than in the placebo group (15 days [95% confidence interval: 12-17 days]). In the clonidine group, 7 infants required restarting opium after initial discontinuation versus none in the placebo group, with the total length of treatment/observation remaining significantly less in the clonidine group. Higher dosages of opium were required by 40% of the infants in the placebo group versus 20% in the clonidine group. Treatment failures occurred in 12.5% of the infants in the placebo group versus none in the clonidine group. Hypertension, hypotension, bradycardia, or desaturations did not occur in either group. Three infants in the clonidine group died as a result of myocarditis, sudden infant death syndrome, and homicide, all after hospital discharge and before 6 months of age.
In this randomized, double-blind trial, adding clonidine to standard opioid therapy for detoxification from in utero exposure to methadone or heroin reduced the duration of pharmacotherapy for neonatal abstinence without causing short-term adverse cardiovascular outcomes. A larger trial is indicated to determine long-term safety.

3 Followers
 · 
133 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: An evidence-based, multidisciplinary neonatal abstinence syndrome protocol was developed using a stepwise continuous quality improvement (CQI) approach with the goal of standardizing care procedures for these infants. A retrospective secondary data analysis was performed to evaluate the differential effects of each step of the CQI project on 4 key clinical outcome measures: length of stay (total and post-opioid wean), weaning time from opioids, and use of adjunct medications. Data were analyzed from 386 newborn infants with a diagnosis of neonatal abstinence syndrome undergoing treatment in a level III neonatal intensive care unit. After implementation of a pharmacologic weaning protocol as a foundational first step of the CQI project, the weaning time from opioids remained stable throughout each of the subsequent CQI steps (P = .905). The overall total neonatal intensive care unit length of stay was reduced by 10.35 days (P = .002), and the length of neonatal intensive care unit stay after completing wean from opioids was reduced by 2.79 days (P < .001). Use of adjunct medications also decreased from 30.1% of infants at the initiation of the CQI project to 24.5% at the completion of the project (P = .020). These findings indicate that this multidisciplinary treatment approach led to an overall improved efficiency of both opioid weaning and symptom management for these infants.
    The Journal of perinatal & neonatal nursing 07/2014; 28(3):232-240. DOI:10.1097/JPN.0000000000000049 · 1.01 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Neonatal abstinence syndrome (NAS) secondary to in-utero opioid exposure is an increasing problem. Variability in assessment and treatment of NAS has been attributed to the lack of high-quality evidence to guide management of exposed neonates. This systematic review examines available evidence for NAS assessment tools, nonpharmacologic interventions, and pharmacologic management of opioid-exposed infants. There is limited data on the inter-observer reliability of NAS assessment tools due to lack of a standardized approach. In addition, most scales were developed prior to the prevalent use of prescribed prenatal concomitant medications, which can complicate NAS assessment. Nonpharmacologic interventions, particularly breastfeeding, may decrease NAS severity. Opioid medications such as morphine or methadone are recommended as first-line therapy, with phenobarbital or clonidine as second-line adjunctive therapy. Further research is needed to determine best practices for assessment, nonpharmacologic intervention, and pharmacologic management of infants with NAS in order to improve outcomes.
    Addiction science & clinical practice 09/2014; 9(1):19. DOI:10.1186/1940-0640-9-19
  • [Show abstract] [Hide abstract]
    ABSTRACT: The incidence of neonatal abstinence syndrome (NAS) has increased dramatically during the past 15 years, likely due to an increase in antepartum maternal opiate use. Optimal care of these patients is still controversial because of the available published literature lacking sufficient sample size, placebo control, and comparative pharmacologic trials. Primary treatment for NAS consists of opioid replacement therapy with either morphine or methadone. Paregoric and tincture of opium have been abandoned because of relative safety concerns. Buprenorphine is emerging as a treatment option with promising initial experience. Adjunctive agents should be considered for infants failing treatment with opioid monotherapy. Traditionally, phenobarbital has been used as adjunctive therapy; however, results of clonidine as adjunctive therapy for NAS appear to be beneficial. Future directions for research in NAS should include validating a simplified scoring tool, conducting comparative studies, exploring home management options, and optimizing management through pharmacogenomics.

Full-text (2 Sources)

Download
55 Downloads
Available from
May 22, 2014