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Recap of safest sedation method for children needed a few more numbers for context

CHEO researchers identify practices leading to safer outcomes in procedural sedation for children

Our Review Summary

Children treated in emergency rooms facing painful procedures are usually given a sedative. This news release on a Canadian study reports that the safest form of sedative among six different drug combinations is ketamine, according to the Children’s Hospital of Eastern Ontario, Canada, which led the study.

This release does a good job of explaining the study methods but leaves out a couple important numbers — the total number of patients studied, and the absolute numbers when describing the safety benefit of ketamine in comparison to the other medications. From the published study we learn that there were about 6,300 participants from six different emergency centers and it took five years to collect the data. These numbers would have made the release stronger.

 

Why This Matters

Each year, thousands of children are brought to the emergency room with injuries requiring painful procedures. How best to sedate children who must undergo these procedures has been an open question with a subtle balance between adequate sedation and independent respiration. There are different schools of thought regarding the best drugs to use with no clear answers overall. This large retrospective study demonstrates an overall adverse event rate of approximately 11 percent with the use of the drug ketamine demonstrating the lowest risk. This large well-designed study adds to clinician understanding of the best approaches to pain management in children arriving in the emergency room.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There was no mention of cost. The costs of a visit to the emergency room can be extensive with the cost of sedation a relatively small part of the overall cost. Even so, ballpark costs of sedation would have been helpful to include.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release did not give absolute numbers for the benefits, just percentages. The main benefit statement is in the excerpt below. We wish the release had told us the number of patients in the groups with the highest and lowest risk for side effects.

“The results of the study show that choice of sedation medication had the biggest impact on the incidence of adverse events and need for significant interventions in response to those events. The incidence of serious adverse events was lowest among patients sedated with ketamine-alone and highest among patients sedated with combination drugs ketamine plus propofol or fentanyl.”

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release did a good job of explaining possible harms that occur in relation to different types of sedation. A few words about the specific adverse events seen with ketamine would have been of value.  As a dissociative agent, ketamine is known for its ability to produce bizarre dreams, and hallucination as well as excessive salivation.

Here is an excerpt from the release:

“The overall incidence of adverse events in the study population was 11.7%. The most common events were a decrease in oxygen saturation (5.6%) and vomiting (5.2%). Significant interventions in response to an adverse event were rare, occurring in only 1.4% of children. Two other practices – receiving an opioid prior to sedation and having a laceration repair – were associated with the occurrence of vomiting, oxygen desaturation and need for significant interventions.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release describes the study as a multi-center observational study that included “children from six emergency departments across Canada, sedated with six different medication combinations.” We wish the release had told us the number of patients studied (6,300), how many received each type of sedation, and the length of the study (five years).

Does the news release commit disease-mongering?

Satisfactory

There was no disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release clearly notes that the study was funded by a federal Canadian program.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release names propofol and fentanyl as two alternatives to ketamine, among the six medications evaluated. We give it credit for providing this general comparison of sedation drugs:

“The incidence of serious adverse events was lowest among patients sedated with ketamine-alone and highest among patients sedated with combination drugs ketamine plus propofol or fentanyl.”

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

The availability of the different sedation methods isn’t addressed. Readers must assume that the study looked at the common types of sedation used.

Does the news release establish the true novelty of the approach?

Satisfactory

The release addresses novelty with the statement:

“According to the authors, this study represents the largest and most robust prospective emergency department procedural sedation cohort to date. It includes children from six emergency departments across Canada, sedated with six different medication combinations.”

While not definitive, this large well-designed study does add to clinician understanding of the best approaches to pain management in children arriving in the emergency room.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t rely on sensational language.  We think the release may have strayed into unjustifiable territory by suggesting the study findings may be “practice-changing.” That remains to be seen but we’ll give the release the benefit of the doubt on this claim.

Total Score: 6 of 9 Satisfactory

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