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Home > "R" Clinical Trials Conditions > Randomized Study of Ketorolac in Infants Undergoing Surgery  Randomized Study of Ketorolac in Infants Undergoing Surgery
Randomized Study of Ketorolac in Infants Undergoing Surgery
For Condition: Intraoperative Complications,Pain,Postoperative Complications
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Children's Hospital and Medical Center - Seattle
Synopsis: OBJECTIVES: I. Determine the pharmacokinetics of ketorolac in infants following surgery. II. Determine the analgesic efficacy of this drug, in terms of infant pain score, time to first opiate medication, and total opioid administration, in these patients. III. Determine the toxicity of this drug in these patients.
Details: PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (0-7 days vs 8-30 days vs 31-90 days vs 91-180 days vs 181-365 days vs 12-18 months). Patients are randomized to one of three treatment arms. Arm I: Patients receive low-dose ketorolac IV over 10 minutes on postoperative day 1 and morphine IV every 1-4 hours as needed. Treatment with ketorolac may continue every 8 hours for 2 days. Arm II: Patients receive high-dose ketorolac and morphine as in arm I. Arm III: Patients receive normal saline IV over 10 minutes on postoperative day 1 and morphine as in arm I. Patients in all arms are assessed for pain score every 2 hours for 4 hours prior to treatment and for 12 hours after treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: /18 Months
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Full-term infants (at least 36 weeks gestation at birth) who are scheduled for one of the following surgeries requiring hospital admission postoperatively: exploratory laparotomy, pyloromyotomy, cleft lip repair, cleft palate repair, craniectomy, placement of ventriculo-peritoneal shunts, urologic surgery (with normal renal function), orthopedic procedures No post-operative analgesia managed with ongoing epidural infusions; single dose caudal epidural injections given intraoperatively allowed --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent gastrotonic agents such as reglan or cisapride; no concurrent coumadin or therapeutic heparin --Patient Characteristics-- Performance status: Not specified Hematopoietic: No patient or family history of bleeding or coagulation defects Hepatic: Hepatic function normal; no prior hepatic transplantation Renal: Renal function normal; no prior renal transplantation Other: No history of gastrointestinal bleeding; no closure of large gastroschisis or omphalocele defects (with increased intra-abdominal pressure); no prior repair of diaphragmatic hernia; no allergy to ketorolac
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
AnneLynn, Study Chair, Children's Hospital and Medical Center - Seattle
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Anne Lynn 206-526-2518
Additional Information:
Study ID Numbers: 199/15737; CHMC-S-FDR001815
Study Start Date: January 2001
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014716
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1. Randomized Study of Ketorolac in Infants Undergoing Surgery
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Randomized Study of Ketorolac in Infants Undergoing Surgery
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