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Ketorolac Safely Controls Postoperative Pain in Children: Presented at AAP

By Crina Frincu-Mallos, PhD
WASHINGTON, DC -- October 22, 2009 -- Ketorolac can be used safely to augment pain control post-operatively in paediatric patients who undergo cardiac surgery, according to research reported here at the 2009 American Academy of Pediatrics (AAP) National Conference & Exhibition (NCE).

Between November 2007 and December 2008, 180 consecutive paediatric patients were admitted to the paediatric intensive care unit (PICU) and underwent cardio-thoracic surgery. Only 77 families gave in-formed consent and those children and infants were randomised to either the ketorolac group (n = 37) or the saline placebo group (n = 36); due to protocol violations, 4 patients dropped out of study.

The children in the 2 groups did not differ in age: those randomised to the placebo group were on average 32.4 months old (range, 16.7-48.1 mo), and the children randomised to the ketorolac group were an average of 35.0 months old (range, 18.6-51.4 mo).

To date, 37 patients safely received ketorolac following cardio-thoracic surgery, said lead author W. Keith Dockery, MD, Pediatric Critical Care Medicine, Inova Fairfax Hospital for Children, Falls Church, Vir-ginia, adding that there was no increase in postoperative bleeding, gastrointestinal bleeding, or impaired renal function in this group, compared with those on placebo.

Control of postoperative pain after cardio-thoracic surgery is especially difficult in the paediatric popula-tion, given that narcotics can cause adverse events such as respiratory depression, hypotension, or de-creased gastrointestinal motility, said Dr. Dockery, who reported the data here October 18, on behalf of colleagues from Inova Fairfax Hospital for Children and collaborators from Pediatric Emergency Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas.

Ketorolac is an intravenous, non-narcotic, nonsteroidal anti-inflammatory drug (NSAID) known to provide some degree of analgesia in the postoperative setting in paediatric and adult patients. However, due to con-cerns about bleeding and renal failure, ketorolac has not been used extensively in paediatric patients recov-ering from cardio-thoracic surgery, explained Dr. Dockery.

The goal of this randomised, blinded, placebo-controlled study was to evaluate the safety and efficacy of postoperative ketorolac in paediatric patients who underwent cardiac surgery.

Each patient in the ketorolac group received their initial dose of study drug soon after arrival in the PICU, then every 8 hours for 2 days, and then once every 24 hours for an additional 3 doses for a maximum of 9 doses over 5 days. The patient was off-study either upon receiving all prescribed doses or upon leaving the PICU.

The investigators noted that patients receiving ketorolac did not have increased postoperative bleeding, as measured by transfusions of blood or blood products, or incidence of heme-positive stools, compared with the placebo group. In addition, paediatric patients in the ketorolac group showed no difference in the change in creatinine or frequency of renal failure, compared with placebo.

In the light of these positive study results, the investigators concluded that ketorolac can be safely used in infants and children following surgery, even surgery involving cardio-pulmonary bypass.

[Presentation title: Safety and Efficacy of Intravenous Ketorolac in Infants and Children Following Cardiac Surgery. Abstract 6803]

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