New Combination Sedative Ketofol Safer for Children

Neil Canavan

May 15, 2013

WASHINGTON, DC — Sedation practices in children can affect patient outcomes. This was the focus of 2 studies presented here at the Pediatric Academic Societies 2013 Annual Meeting.

In the first, the detection and correction of inappropriate procedural sedation practices in children resulted in a 14% reduction in adverse events in just a few months.

"We observed that sedation practices varied because of individual preferences, institutional culture, and a lack of evidence-based guidelines," said study coordinator Maala Bhatt, MD, from Montreal Children's Hospital in Quebec, Canada. "Unfortunately, these variations can affect patient outcomes."

To examine sedation practices, Dr. Bhatt and colleagues used a database to prospectively enroll children undergoing procedural sedation at 5 Canadian pediatric emergency departments.

An audit of the database produced "striking" results, Dr. Bhatt reported. "We detected a medication combination that resulted in adverse event rates 2 to 7 times greater than other sedation protocols.... And these events were severe."

That combination was ketamine plus fentanyl. "In children who experienced oxygen desaturation, the rate of positive pressure ventilation was 4 times that of ketamine alone." Rates for nausea and vomiting were also much higher.

The audit also revealed that the combination was being used in 51% of sedations at a single site.

The researchers implemented an intervention at that site to improve the quality of sedation and reduce adverse events by decreasing the use of ketamine plus fentanyl for procedural sedation.

Dr. Bhatt presented the results of that intervention.

Findings from a new literature review were then discussed with the sedation teams, and physicians were encouraged to discontinue the use of ketamine plus fentanyl. At the same time, physicians were made aware of a newly available combination of ketamine and propofol, known as ketofol.

"After the face-to-face meeting, an email was sent to the group reinforcing the adoption of the new practices and discontinuing the old," Dr. Bhatt said.

Another audit of the database was performed a few months later to gage the effectiveness of the intervention.

Dr. Bhatt reported that the use of ketamine plus fentanyl decreased from 51% to 6% at the study site, and the use of ketofol greatly increased. "The intervention site determined the nature of the protocol change; we recommended that they stop the ketamine/fentanyl combination, but it was their decision to use ketofol."

The switch resulted in a 14% decrease in adverse events overall, a 7% decrease in oxygen desaturation, and a 9% decrease in nausea and vomiting. The decrease in desaturation requiring positive pressure ventilation was 35%.

Such a database "has the potential to identify other practices in which patient outcomes may be adversely affected by inappropriate variations in care," said Dr. Bhatt.

However, despite the success of the program, Dr. Bhatt did have one qualm. "The ketamine plus fentanyl combination was still being used in 6% of sedation procedures after the intervention, highlighting the need for further intervention."

Results from the second study, presented by Melissa Langhan, MD, from the Yale University School of Medicine in New Haven, Connecticut, showed that the procedural sedation of children monitored with capnography reduces the incidence of hypopneic hypoventilation.

Capnography During Sedation

"Hypopneic hypoventilation — a decrease in tidal volume without a change in respiratory rate — is not easily detected with standard monitoring practices during sedation," Dr. Langhan explained. However, it can be detected with capnography, and earlier detection can lead to earlier interventions to prevent hypoxemia.

In a previous observational study, Dr. Langhan and colleagues found that 28% of ketamine-sedated patients in the emergency department were hypoventilated (Pediatr Emerg Care. 2011;27:394-397). In addition, in 71% of patients, hypoxemia was preceded by hypoventilation, and that hypoventilation preceded decreases in pulse oximetry by a mean of 3.7 minutes. "This gives us a window of opportunity to intervene."

 
This gives us a window of opportunity to intervene.
 

For the current study, Dr. Langhan and colleagues enrolled 154 patients. All patients received both standard monitoring and capnography with a nasal–oral cannula for procedural sedation, and were then randomized to 1 of 2 groups. In the first group of 77 patients, staff was blinded to the capnography monitor screen; in the second group of 77 patients, which served as the control, the screen was visible.

"Prior to all this, we first had to educate our staff because this was not our standard practice," Dr. Langhan noted.

During sedation, vital signs were recorded every 30 seconds, and staff interventions, if any, were noted.

There was a marked reduction in hypoventilation in the control group (= .008). All events were hypopneic, and end-tidal CO2 was less than 30 mm Hg. "The likelihood of this event increased over time in both groups, but increased significantly faster in the control group," Dr. Langhan reported.

The odds of an intervention — the majority of which were stimulation and airway maneuvers — were significantly lower in the blinded group than in the control group (< .001).

There were no significant differences in the likelihood of oxygen desaturation between the 2 groups.

Reaction to this study was mixed; audience members said they were unclear about the utility of the method. One physician acknowledged the seriousness of the issue of desaturation, but wondered just how many patients would have to be treated to avoid a single case. "This is yet another thing we would need to do in the course of monitoring sedation, and I need to be convinced that it's worth the effort."

Dr. Bhatt and Dr. Langhan have disclosed no relevant financial relationships.

Pediatric Academic Societies (PAS) 2013 Annual Meeting: Abstracts 1680.4 and 1681.1. Presented May 4, 2013.

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