Ketorolac for short-term pain after surgery in children

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Ketorolac for short-term pain after surgery in children

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Authors: 
McNicol ED, Rowe E, Cooper TE

Bottom line
There is no good evidence from studies to support or reject the suggestion that ketorolac is beneficial, or that it is associated with serious side effects in treating children’s pain after surgery.

Background
Children are at risk of experiencing pain in the short term after surgery. Nonsteroidal anti-inflammatory drugs (NSAIDs, e.g. aspirin) can reduce moderate to severe pain without many of the side effects associated with opioids (drugs like morphine). However, NSAIDs may cause bleeding and injury to the kidneys and gut. Ketorolac is an NSAID that can be given by injection into a vein, which may be useful when patients are not able to take medicines by mouth. Despite the fact that ketorolac has not been approved for use in children by many government agencies, it is often used after surgery, because of a lack of alternative options.

Study characteristics
In November 2017, we searched for clinical trials where ketorolac was used to treat pain after surgery in children. We found 13 studies, enrolling 920 children, that met our requirements for the review. The studies were quite different in their design, the dose of ketorolac, the timing (during or after surgery) and number of doses given, the type of surgery, and to what ketorolac was compared (either a placebo (a dummy treatment, such as a bag of fluid) or another drug).

Key findings

There was not enough information for a statistical analysis of the assessments in which we were most interested, that is, the number of children with at least 50% pain relief; or the average pain intensity (a measure of a patient’s pain that asks the patient to rate how much pain they have, often on a scale of 0 for ‘no pain’ to 10 for ‘worst pain imaginable’). Four studies individually reported that ketorolac was better at reducing pain intensity than placebo, but the studies were small and had various design issues. There was more information for other assessments, such as the number of children who needed rescue medication (additional pain medication that is given if the study medication is not helping the person’s pain sufficiently), and how much of this rescue medication was used. Fewer children needed rescue medication in the ketorolac group than those who received placebo, although the result was not statistically different. During the four hours after they received study medications, children receiving ketorolac needed slightly less rescue pain medication than those who had received placebo. There was not enough information about ketorolac in direct comparisons with other medications.

There was also not enough information in the studies for us to make a good assessment of side effects and serious side effects when ketorolac was used in this setting. Serious side effects in those receiving ketorolac included bleeding, but it didn’t occur often enough for us to make any firm conclusions. Very few children dropped out of the studies because of side effects. This is normal in studies where participants are only in the study for a short period of time.

Quality of the evidence
We rated the quality of the evidence as very low, due to methodological issues with many of the studies, differences in study designs, and low overall numbers of children enrolled. Very low-quality evidence means that we are very uncertain about the results.

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