Ketorolac in Postoperative Infants: Pharmacokinetics and Safety

Seattle Children's Healthcare System

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain in Infants

Treatments: Drug: Placebo; Drug: Ketorolac Tromethamine 1 mg/kg; Drug: Ketorolac Tromethamine 0.5 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT01260883

IND 59883

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 2 to 18 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 3 patient groups

ketorolac 1 mg/kg

Experimental group

Description:

ketorolac 1 mg/kg iv given by 10 min infusion

Treatment:

Drug: Ketorolac Tromethamine 1 mg/kg

ketorolac 0.5 mg/kg

Active Comparator group

Description:

ketorolac 0.5 mg/kg iv given by 10 min infusion

Treatment:

Drug: Ketorolac Tromethamine 0.5 mg/kg

placebo

Sham Comparator group

Description:

placebo group received D5W 10 min infusion

Treatment:

Drug: Placebo