Could skipping opioids make Kids' cleft surgery safer?
NCT ID NCT07557576
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether an opioid-free anesthesia approach using ketamine and dexmedetomidine can control pain and reduce agitation just as well as standard opioid anesthesia in 90 children aged 3 months to 7 years undergoing cleft lip or palate repair. Researchers will measure pain, agitation, and stress markers after surgery. The goal is to find a safer way to manage pain with fewer side effects like nausea and breathing trouble.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Ketamine, Dexmedetomidine, Fentanyl, Propofol, Sevoflurane
- What this could lead to
- If successful, this could show that opioid-free anesthesia is safer and just as effective for children undergoing cleft surgery, reducing side effects like nausea and breathing problems.
- What could go wrong
- This is a small, early-stage trial (90 children) comparing two approaches, so results may not apply to all children or surgeries. The opioid-free method might not control pain as well as expected.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University Hospital Dubrava
RECRUITINGZagreb, 10000, Croatia
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Other studies related to the condition(s) this trial covers.
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