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.

Condition	Treatment or Intervention
Pain Intraoperative Complications Postoperative Complications	Drug: ketorolac

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.

Ages Eligible for Study:  up to  18 Months,  Genders Eligible for Study:  Both

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

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States; Recruiting

Study chairs or principal investigators

Anne M. Lynn,  Study Chair,  Children's Hospital and Medical Center - Seattle   

Study ID Numbers:  199/15737; CHMC-S-FDR001815
Record last reviewed:  May 2001
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014716
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09