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.
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.
PROTOCOL ENTRY CRITERIA:
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
No post-operative analgesia managed with ongoing epidural infusions; single dose caudal
epidural injections given intraoperatively allowed
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
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