Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants
研究概览
简要总结
Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.
详细描述
Population kinetic analysis of ketorolac stereo-isomer concentrations after single dose given postoperatively in infants aged 2-18 months. Safety assessments of renal and hepatic function tests by blood tests before and after drug administration, urinalysis pre- and post-drug, continuous oximetry before and for 12 hours after drug. Morphine use between active drug groups and placebo group in the first 24 hours after surgery was assessed as a surrogate analgesic measure in these non-verbal infants. A modified infant pain scale was used to assure consistent pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-prematurely-born infants admitted to hospital following surgery ages 2-18 months, studied by age group 12-18 months, 6-12 months, < 6 months
排除标准
- •Bleeding history in infant or family
- •Coagulopathy
- •Gastrointestinal bleeding history
- •Renal or hepatic disease assessed by history and by pre-drug blood tests
- •Premature birth (<36 weeks gestation)
研究组 & 干预措施
ketorolac 1 mg/kg
ketorolac 1 mg/kg iv given by 10 min infusion
干预措施: Ketorolac Tromethamine 1 mg/kg (Drug)
ketorolac 0.5 mg/kg
ketorolac 0.5 mg/kg iv given by 10 min infusion
干预措施: Ketorolac Tromethamine 0.5 mg/kg (Drug)
placebo
placebo group received D5W 10 min infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants
时间窗: 24 hours after surgery
population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery
Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery
时间窗: 24 hours following surgery
stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)
Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants
时间窗: 24 hours after surgery
stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants
Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants
时间窗: 24 hours post surgery
peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)
Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants
时间窗: 24 hours after surgery
half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery
Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants
时间窗: 24 hours after surgery
stereo-specific ketorolac clearance by population-based analysis (NONMEM)
Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants
时间窗: 24 hours after surgery
population-based analysis of ketorolac stereo-isomers
Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery
时间窗: 24 hours after surgery
noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants
次要结局
- Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery(first day after surgery)
- Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants(12 hours after ketorolac or placebo infusion)
- Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery(24 hours after surgery)
- Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants(24 hours after surgery)
研究者
Anne M. Lynn
Professor, Anesthesiology and Pediatrics
Seattle Children's Hospital