Abstract

This is an application to become a member of the NICHD Pediatric Pharmacology Research Unit Network to increase the study of medications in pediatric subjects, increase understanding of developmental changes in drug metabolism, and increase labeling of drugs for the pediatric population. As part of this application, we propose to study the pharmacokinetics of morphine and its metabolism into glucuronides during a 72 hr infusion. The efficacy of morphine will be determined with validated pain scales and bispectral analysis of infant EEG. Another study proposes a randomized, blinded comparison of the development of tolerance and abstinence during treatment of neonates with fentanyl and morphine for sedation and analgesia during mechanical ventilation. Predictors of tolerance will be determined based on pharmacologic measures of exposure. The effectiveness of clonidine for treatment of abstinence syndrome in neonates will be determined in an open-label treatment. A third study will determine the systemic exposure to local anesthetics contained in the S-Caine topical local anesthetic patch.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD045986-02
Application #
6853593
Study Section
Special Emphasis Panel (ZHD1-DSR-A (01))
Program Officer
Giacoia, George
Project Start
2004-02-15
Project End
2008-12-31
Budget Start
2005-01-01
Budget End
2005-12-31
Support Year
2
Fiscal Year
2005
Total Cost
$372,321
Indirect Cost

  Institution

Name
University of Utah
Department
Pediatrics
Type
Schools of Medicine
DUNS #
009095365
City
Salt Lake City
State
UT
Country
United States
Zip Code
84112

  Publications

Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Redwine, Karen M; James, Laura P; O'Riordan, MaryAnn et al. (2015) Accuracy of the Spacelabs 90217 ambulatory blood pressure monitor in a pediatric population. Blood Press Monit 20:295-8
Ward, Robert M; Sweeley, John; Lugo, Ralph A (2015) Inositol Analysis by HPLC and Its Stability in Scavenged Sample Conditions. Med Chem (Los Angeles) 5:077-80
Ward, Robert M; Drover, David R; Hammer, Gregory B et al. (2014) The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth 24:591-601
Fukuda, Tsuyoshi; Goebel, Jens; Cox, Shareen et al. (2012) UGT1A9, UGT2B7, and MRP2 genotypes can predict mycophenolic acid pharmacokinetic variability in pediatric kidney transplant recipients. Ther Drug Monit 34:671-9
Redwine, Karen; Howard, Lee; Simpson, Pippa et al. (2012) Effect of placebo on ambulatory blood pressure monitoring in children. Pediatr Nephrol 27:1937-42
Tammara, Brinda K; Sullivan, Janice E; Adcock, Kim G et al. (2011) Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet 50:541-50
Ward, Robert M; Kearns, Gregory L; Tammara, Brinda et al. (2011) A multicenter, randomized, open-label, pharmacokinetics and safety study of pantoprazole tablets in children and adolescents aged 6 through 16 years with gastroesophageal reflux disease. J Clin Pharmacol 51:876-87
Price, K E; Pearce, R E; Garg, U C et al. (2011) Effects of valproic acid on organic acid metabolism in children: a metabolic profiling study. Clin Pharmacol Ther 89:867-74
Kern, Steven E (2009) Challenges in conducting clinical trials in children: approaches for improving performance. Expert Rev Clin Pharmacol 2:609-617

Showing the most recent 10 out of 17 publications