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Completed

NCT Number: NCT01260883

Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

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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Key information

Conditions

Postoperative Pain in Infants

Age range

2 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketorolac Tromethamine 1 mg/kg

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.

Other names: toradol

Ketorolac Tromethamine 0.5 mg/kg

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.

Other names: toradol

Placebo

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.

Other names: Dextrose in water (D5W)

Primary outcomes

  1. Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery

    Time frame: 24 hours following surgery

    stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)

  2. Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants

    Time frame: 24 hours after surgery

    stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants

  3. Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants

    Time frame: 24 hours post surgery

    peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)

  4. Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants

    Time frame: 24 hours after surgery

    half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery

  5. Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants

    Time frame: 24 hours after surgery

    stereo-specific ketorolac clearance by population-based analysis (NONMEM)

  6. Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants

    Time frame: 24 hours after surgery

    population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery

  7. Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants

    Time frame: 24 hours after surgery

    population-based analysis of ketorolac stereo-isomers

  8. Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery

    Time frame: 24 hours after surgery

    noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants

Secondary outcomes

  1. Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery

    Time frame: first day after surgery

    total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo

  2. Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants

    Time frame: 12 hours after ketorolac or placebo infusion

    continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo

  3. Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery

    Time frame: 24 hours after surgery

    total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery

  4. Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants

    Time frame: 24 hours after surgery

    continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2000
Primary completion
2008
Study completion
2010
First posted
Dec 15, 2010
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.