Randomized Study of Ketorolac in Infants Undergoing Surgery

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, May 2001

First Received: April 10, 2001 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Seattle Children's Hospital
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00014716

Purpose

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	Intervention
Pain Intraoperative Complications Postoperative Complications	Drug: ketorolac

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Ketorolac Ketorolac tromethamine

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	90
Study Start Date:	January 2001

Detailed Description:

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

Ages Eligible for Study:	up to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014716

Locations

United States, Washington
Children's Hospital and Regional Medical Center - Seattle	Recruiting
Seattle, Washington, United States, 98105
Contact: Anne M. Lynn 206-526-2518

Sponsors and Collaborators

FDA Office of Orphan Products Development

Seattle Children's Hospital

Investigators

Study Chair:

Anne M. Lynn

Seattle Children's Hospital

More Information

No publications provided

Study ID Numbers:	199/15737, CHMC-S-FDR001815
Study First Received:	April 10, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00014716 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

disease-related problem/condition pain
perioperative/postoperative complications
rare disease

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ketorolac
Cyclooxygenase Inhibitors
Rare Diseases
Pain
Intraoperative Complications
Postoperative Complications

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Ketorolac Tromethamine
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Ketorolac
Physiological Effects of Drugs
Enzyme Inhibitors
Intraoperative Complications
Pharmacologic Actions
Pathologic Processes
Postoperative Complications

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Ketorolac Tromethamine
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009