Randomized Study of Ketorolac in Infants Undergoing Surgery



Status:Archived
Conditions:Chronic Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:Any
Updated:7/1/2011

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Trial Summary
Trial Overview
Inclusion Criteria


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.


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.


We found this trial at
1
site
Children's Hospital and Regional Medical Center - Seattle
4800 Sand Point Way Northeast
Seattle, Washington 98105
(206) 987-2000
Children's Hospital and Regional Medical Center - Seattle Seattle Children
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mi
from
Seattle, WA
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