Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain in Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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ketorolac 1 mg/kg

ketorolac 1 mg/kg iv given by 10 min infusion

Group Type EXPERIMENTAL

Ketorolac Tromethamine 1 mg/kg

Intervention Type DRUG

Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

ketorolac 0.5 mg/kg

ketorolac 0.5 mg/kg iv given by 10 min infusion

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine 0.5 mg/kg

Intervention Type DRUG

Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

placebo

placebo group received D5W 10 min infusion

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

Interventions

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Ketorolac Tromethamine 1 mg/kg

Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

Intervention Type DRUG

Ketorolac Tromethamine 0.5 mg/kg

Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

Intervention Type DRUG

Placebo

Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.

Intervention Type DRUG

Other Intervention Names

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toradol toradol Dextrose in water (D5W)

Eligibility Criteria

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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)

Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No