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

    RECRUITING

    Zagreb, 10000, Croatia

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