Ketorolac in Postoperative Infants: Pharmacokinetics and Safety - Full Text View

Sponsor:	Seattle Children's Hospital
Collaborator:	University of Washington
Information provided by:	Seattle Children's Hospital
ClinicalTrials.gov Identifier:	NCT01260883

Purpose

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.

Condition	Intervention	Phase
Ketorolac Pharmacokinetics in Infants Ketorolac Safety in Infants	Drug: Ketorolac Tromethamine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Resource links provided by NLM:

Drug Information available for: Ketorolac Ketorolac tromethamine Tromethamine

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:

pharmacokinetics of ketorolac stereo-isomers in 6-18 month old infants [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]
single iv dose of drug (or placebo) following surgery with blood sampling for 12 hours after study drug given. Pharmacokinetic analysis of stereo-isomers using population methodology (NONMEM)to report clearance, volumes of distribution and half-lives for ketorolac isomers in infants.

Secondary Outcome Measures:

pharmacokinetics of ketorolac in 2-6 month old infants following surgery [ Time Frame: 24 hours following surgery ] [ Designated as safety issue: No ]
same as for older infants

Enrollment:	51
Study Start Date:	May 2000
Study Completion Date:	December 2010
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ketorolac 1 mg/kg ketorolac 1 mg/kg iv given by 10 min infusion	Drug: Ketorolac Tromethamine study drug iv infusion over 10 minutes was either 1 mg/kg ketorolac, 0.5 mg/kg ketorolac or placebo. Blood sampling in all groups for up to 12 hours after infusion for ketorolac concentrations and safety assessments.
Active Comparator: ketorolac 0.5 mg/kg ketorolac 0.5 mg/kg iv given by 10 min infusion	Drug: Ketorolac Tromethamine study drug iv infusion over 10 minutes was either 1 mg/kg ketorolac, 0.5 mg/kg ketorolac or placebo. Blood sampling in all groups for up to 12 hours after infusion for ketorolac concentrations and safety assessments.
Sham Comparator: placebo placebo group received D5W 10 min infusion	Drug: Ketorolac Tromethamine study drug iv infusion over 10 minutes was either 1 mg/kg ketorolac, 0.5 mg/kg ketorolac or placebo. Blood sampling in all groups for up to 12 hours after infusion for ketorolac concentrations and safety assessments.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	2 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260883

Locations

United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Seattle Children's Hospital

University of Washington

Investigators

Principal Investigator:

Anne M. Lynn, MD

Seattle Children's Hospital

More Information

Publications:

Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents.

Responsible Party:	Anne Lynn MD, Professor, Anesthesiology and Pediatrics, Dept. Anesthesiology, Seattle Children's Hospital/University of Washington
ClinicalTrials.gov Identifier:	NCT01260883 History of Changes
Obsolete Identifiers:	NCT00014716
Other Study ID Numbers:	IND 59883
Study First Received:	December 9, 2010
Last Updated:	December 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Children's Hospital:

ketorolac pharmacokinetics
ketorolac stereo-isomers
infants
postoperative analgesia
safety

Additional relevant MeSH terms:

Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012