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PRIME RCT – Ketamine or Fentanyl Intranasal For Pediatric Injuries?

February 27, 2019

Written by Vivian Lei

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Intranasal ketamine is noninferior to intranasal fentanyl for pain associated with pediatric extremity injuries. However, there is a higher risk of minor adverse events.

Why does this matter?
Intranasal medication administration is fast, simple, and effective. Sub-dissociative ketamine is an opioid sparing alternative for pain management and can be a helpful addition to our toolkit for pediatric patients. This trial sought to determine whether intranasal sub-dissociative ketamine is noninferior to intranasal fentanyl for the treatment of acute pain associated with traumatic limb injuries in children who were not routinely administered ibuprofen or acetaminophen.

PRIME time to insufflate ketamine
In this emergency department-based RCT, the Pain Reduction with Intranasal Medications for Extremity Injuries (PRIME) trial, 90 children were randomized to receive intranasal ketamine (1.5 mg/kg) or intranasal fentanyl (2 mcg/kg). At 30 minutes after medication administration, the mean visual analog scale reduction was 30.6 mm (95% CI 25.4 mm – 35.8 mm) for children that received ketamine, and 31.9 mm (95% CI 26.6 mm – 37.2 mm) for children that received fentanyl. There were no significant differences observed in sedation scores, mean capnometry values, vital signs, or need for additional rescue analgesia between the two groups. There were more adverse events in the ketamine group (77% vs. 31%, RR 2.5 with 95% CI of 1.5 – 4.0), most commonly dizziness, drowsiness, and unpleasant taste. However, all adverse events were minor and transient. This study, therefore, shows that the use of intranasal ketamine is effective analgesia that is noninferior to fentanyl in children with acute extremity injuries.

Effect of Intranasal Ketamine vs Fentanyl on Pain Reduction for Extremity Injuries in Children: The PRIME Randomized Clinical Trial. JAMA Pediatr. 2018 Dec 28. doi: 10.1001/jamapediatrics.2018.4582. [Epub ahead of print]

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Reviewed by Clay Smith

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