Trial reportPediatrics2009
Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial.
Trial report in Pediatrics, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 56 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Clonidine in Reducing Iatrogenic-induced Opioid Dependence in Infants:
Phase I-II Clinical Trial to Determine the Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Who cites it
56 citing papers in PubMed, 6 syntheses or guidelines pooled it, 178 citations in OpenAlex.
- Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Sedatives for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review.Trials · 2020Pooled it
- Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019Pooled it
- Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis.JAMA pediatrics · 2019Pooled it
- Review of the assessment and management of neonatal abstinence syndrome.Addiction science & clinical practice · 2014Pooled it
- Pharmacokinetic Modeling and Model-Based Hypothesis Generation for Dose Optimization of Clonidine in Neonates With Neonatal Opioid Withdrawal Syndrome.Clinical pharmacology and therapeutics · 2025Trial
- Comparison of the effect of phenobarbital & levetiracetam in the treatment of neonatal abstinence syndrome (NAS) as adjuvant treatment in neonates admitted to the neonatal intensive care unit: a randomized clinical trial.BMC pregnancy and childbirth · 2024Trial
- Mechanistic Population Pharmacokinetics of Morphine in Neonates With Abstinence Syndrome After Oral Administration of Diluted Tincture of Opium.Journal of clinical pharmacology · 2016Trial
- Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.Journal of perinatology : official journal of the California Perinatal Association · 2013Trial
- Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome.Addiction (Abingdon, England) · 2011Trial
- Clinical Efficacy and Risks of Clonidine Infusion for Sedation and Analgesia: A Narrative Review.Current pain and headache reports · 2026Review
- Fentanyl exposure during preconception and gestation permanently dysregulates endogenous opioid peptides and sympathoadrenal-medullary axis in the offspring.Clinical science (London, England : 1979) · 2025Article
- Sedation and Pain Management in Neonates Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy.Children (Basel, Switzerland) · 2025Review
- Optimal Dosing Recommendations of Clonidine in Pediatrics Using Physiologically Based Pharmacokinetic Modeling.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Oral Clonidine-Based Strategy to Reduce Opiate Use During Cooling for Neonatal Encephalopathy: An Observational Study.The Journal of pediatrics · 2024Observational
- Limited bedding and nesting increases ethanol drinking in female rats.Pharmacology, biochemistry, and behavior · 2024Article
- Neonatal Abstinence Signs during Treatment: Trajectory, Resurgence and Heterogeneity.Children (Basel, Switzerland) · 2024Article
- Future Newborns with Opioid-Induced Neonatal Abstinence Syndrome (NAS) Could Be Assessed with the Genetic Addiction Risk Severity (GARS) Test and Potentially Treated Using Precision Amino-Acid Enkephalinase Inhibition Therapy (KB220) as a Frontline Modality Instead of Potent Opioids.Journal of personalized medicine · 2022Review
- Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy.Therapeutic innovation & regulatory science · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
Abstract
objectiveTo determine if oral clonidine would reduce the duration of opioid detoxification for neonatal abstinence syndrome.
methodsInfants 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.
resultsThe 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.
conclusionsIn 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.