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Using intranasal ketamine instead of intranasal fentanyl results in similar effectiveness and an increase of only minor adverse events in children with suspected extremity fractures, according to a new study published in Academic Emergency Medicine (AEM). The increased adverse effects included dizziness and a bad taste in the mouth, report authors of the study, which was led by researchers from Carolinas Medical Center/Levine Children's Hospital in Charlotte, NC.
The goal of the study was to pave the way for a larger noninferiority trial that could investigate the use of intranasal ketamine as a way to avoid opioids, researchers note. In the exploratory analysis, they detected no serious adverse events and noted that none of the side effects for either ketamine or fentanyl required treatment.
For the randomized controlled trial conducted at an urban Level II pediatric trauma center from December 2015 to November 2016, administration of 1 mg/kg intranasal ketamine was compared to 1.5 μg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures. Of 629 patients screened, 87 received the study drug and 82, with a median age of 8, had complete data for the primary outcome. The participants, 62% male, had similar baseline pain scores before receiving the intranasal drugs.
The primary outcome reported in the blinded study was how often cumulative side effects and adverse events occurred within 60 minutes of drug administration. After the painkillers were administered, all patients were monitored for six hours or until they were either admitted or moved to a surgical suite.
Results indicate that the rate of side effects was 2.2 times higher in the ketamine group, with bad taste in the mouth as the most common complaint, noted for 90.2% of participants; followed by dizziness, noted for 73.2%; and sleepiness, noted for 46.3%, according to the article. At the same time, the most common side effects of fentanyl were sleepiness, noted for 36.6%, bad taste in the mouth, noted for 22%, and itchy nose, noted for 22%. No respiratory effects were documented in any of the patients.
“Intranasal ketamine was associated with more minor side effects than intranasal fentanyl,” study authors conclude. “Pain relief at 20 minutes was similar between groups. Our data support the feasibility of a larger, noninferiority trial to more rigorously evaluate the safety, efficacy, and potential opioid-sparing benefits of intranasal ketamine analgesia for children with acute pain.”