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Intranasal sufentanil-ketamine appears safe, effective for pediatric acute pain

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Intranasal sufentanil-ketamine appears safe, effective for pediatric acute pain

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Intranasal sufentanil-ketamine is fast-acting and appears to be well tolerated and effective at curbing acute pain for pediatric patients in the emergency department, according to a study presented at the annual European Emergency Medicine Congress, held Sept. 23–27 in Paris.

Shammi Ramlakhan, M.B.B.S., from Sheffield Children's Hospital in the United Kingdom, and colleagues evaluated the efficacy, safety and tolerability of a fixed-dose intranasal formulation of sufentanil-ketamine. The phase 2/3 study included 152 patients (aged ≥1 to <18 years) presenting to the emergency department with moderate-to-severe acute pain.

The researchers found that 54% and 88% of participants had a pain intensity score of ≤4 at 15 and 30 minutes, respectively. Nearly all patients (95.4%) achieved a 30% reduction in pain intensity, and 86.2% achieved a 50% reduction from baseline at 30 minutes. Across all age groups, the median treatment satisfaction score was 5 out of 5 (very satisfied), with 92% acceptability.

Just under half of participants (49.7%) reported at least one adverse event, and 46.5% reported treatment-emergent adverse events. No severe adverse events were reported, and nearly all (94%) were mild. Across all age groups, sedation scores were a median of 0 (awake and alert) or 1 (minimally sedated).

"Pain in children remains underrecognized and undertreated. Our research shows that this drug can provide rapid and meaningful pain relief for children being treated in the emergency department," Ramlakhan said in a statement.


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