Intranasal Sufentanil-Ketamine Shows Fast Relief for Pediatric Acute Pain

A New Option for Children in Acute Pain

Emergency departments have long faced a difficult gap when treating children who arrive in significant pain. Many of the tools available to clinicians were developed and studied primarily in adults, leaving physicians to weigh uncertain dosing, unfamiliar side-effect profiles and invasive delivery methods against the urgent need to relieve suffering. New research presented at the annual European Emergency Medicine Congress, held Sept. 23–27 in Paris, suggests a fixed-dose nasal spray combining two well-known analgesic agents may help close that gap.

The phase 2/3 study evaluated an intranasal formulation of sufentanil and ketamine, delivered as a single fixed dose, in young patients arriving at the emergency department with moderate-to-severe acute pain. According to the findings, the combination acted quickly, appeared well tolerated, and produced clinically meaningful reductions in pain for the great majority of participants.

How the Study Was Conducted

The trial, led by Shammi Ramlakhan, M.B.B.S., of Sheffield Children's Hospital in the United Kingdom, and colleagues, enrolled 152 patients ranging in age from one year to under 18 years. Every participant presented to the emergency department with acute pain of moderate or severe intensity — the kind of injury or illness that calls for prompt intervention rather than watchful waiting.

The researchers set out to measure three things: whether the drug combination actually reduced pain, whether it was safe, and whether children and their families tolerated the experience of receiving it. Because the formulation is administered through the nose, it avoids the need for intravenous access, a step that can be distressing for young patients and time-consuming for busy clinical teams.

Pairing an opioid such as sufentanil with ketamine is not a new concept in anesthesia and emergency care; the two drugs are frequently combined to provide analgesia while limiting the respiratory depression that can accompany opioids used alone. What is new here is packaging them into a single, fixed-dose intranasal product designed specifically for pediatric use, then testing it prospectively in an emergency setting.

Relief Arrived Within Minutes

The speed of the response was among the study's most striking findings. Pain intensity scores were recorded at set intervals after dosing, and the results showed a rapid onset of effect.

• At 15 minutes, 54 percent of participants had a pain intensity score of 4 or lower.
• By 30 minutes, that figure had risen to 88 percent.
• Nearly all patients — 95.4 percent — achieved at least a 30 percent reduction in pain intensity from baseline at 30 minutes.
• 86.2 percent reached a 50 percent reduction from baseline over the same period.

For parents and clinicians alike, those numbers matter in practical terms. A child who arrives screaming after a fracture, a burn or an acute abdomen typically waits through triage, assessment and, often, intravenous line placement before serious analgesia begins. An intranasal option that produces measurable relief within a quarter of an hour could reshape that timeline.

Safety Signals Look Reassuring

Any new analgesic for children faces intense scrutiny over safety, and the investigators reported no severe adverse events among the 152 participants. Just under half — 49.7 percent — experienced at least one adverse event of any kind, and 46.5 percent reported treatment-emergent adverse events. Importantly, 94 percent of those events were classified as mild.

The most closely watched concern with opioid-based sedation is excessive drowsiness or depressed breathing. On sedation scoring, participants across all age groups recorded a median score of either 0, meaning awake and alert, or 1, meaning minimally sedated. That profile suggests the ketamine component and the fixed dosing strategy may help keep children comfortable without oversedating them.

High Satisfaction Among Patients and Families

Beyond raw pain scores, the study tracked how acceptable the treatment was to those receiving it. Across every age group, the median treatment satisfaction score was a perfect 5 out of 5, described as "very satisfied," and overall acceptability reached 92 percent.

That measure carries real weight in pediatric medicine, where a treatment that works but terrifies the patient can complicate future care. Needle-free delivery is a meaningful advantage in a population that frequently associates the emergency department with painful procedures.

Why Pediatric Pain Is Still Undertreated

Ramlakhan framed the results against a persistent clinical problem. "Pain in children remains underrecognized and undertreated," he said in a statement. "Our research shows that this drug can provide rapid and meaningful pain relief for children being treated in the emergency department." He added that the findings give doctors "a simple and effective option for treating their patients where very few options currently exist."

The scarcity Ramlakhan describes is familiar to emergency clinicians. Many analgesics used in children are administered off-label, dosed by weight and extrapolated from adult data. Intravenous access can be difficult in small, frightened patients, and any delay in obtaining it delays relief. Oral routes are slower and unreliable in children who are nauseated or uncooperative. A fixed-dose nasal spray sidesteps several of those obstacles at once.

What the Findings Do and Do Not Show

The results come from a phase 2/3 trial, a stage designed to establish both preliminary efficacy and a clearer picture of safety across a defined population. With 152 participants, the study is large enough to detect common adverse events but not rare ones, and the data were presented at a medical congress, meaning they have not necessarily undergone the full peer review that accompanies journal publication.

Questions remain about how the formulation performs outside a controlled study setting, how it compares head-to-head with existing standards of care, and whether a single fixed dose holds up across the full weight range of children from toddlers to teenagers. Longer follow-up would also help clarify how often sedation or other effects interfere with discharge decisions in a crowded emergency department.

The Bigger Picture for Emergency Care

Even with those caveats, the direction of the evidence is notable. An effective, needle-free, fast-acting analgesic for pediatric acute pain would address a gap that clinicians have worked around for decades rather than solved. It would also fit the broader push in emergency medicine toward treatments that are simpler to administer, less traumatic for patients and easier to deploy when staff and time are stretched thin.

Further analysis and peer-reviewed publication will determine whether intranasal sufentanil-ketamine becomes a standard tool in pediatric emergency care or remains a promising signal from an early-stage trial. For now, the study offers something uncommon in this corner of medicine: a plausible answer to a problem that has long gone underaddressed.

This article is based on reporting by Medical Xpress. Read the original article.