Abstract | OBJECTIVE: STUDY DESIGN: Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. RESULTS: A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. CONCLUSION:
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Authors | B Surran, P Visintainer, S Chamberlain, K Kopcza, B Shah, R Singh |
Journal | Journal of perinatology : official journal of the California Perinatal Association
(J Perinatol)
Vol. 33
Issue 12
Pg. 954-9
(Dec 2013)
ISSN: 1476-5543 [Electronic] United States |
PMID | 23949834
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenergic alpha-2 Receptor Agonists
- Analgesics, Opioid
- Morphine
- Clonidine
- Phenobarbital
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Topics |
- Adrenergic alpha-2 Receptor Agonists
(administration & dosage, therapeutic use)
- Analgesics, Opioid
(administration & dosage, adverse effects)
- Analysis of Variance
- Clonidine
(administration & dosage, therapeutic use)
- Drug Therapy, Combination
- Female
- Humans
- Infant, Newborn
- Male
- Morphine
(administration & dosage)
- Neonatal Abstinence Syndrome
(drug therapy)
- Phenobarbital
(therapeutic use)
- Prospective Studies
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