New nebulizer mix may ease Kids' surgery anxiety
NCT ID NCT05821972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to sedate children before cleft palate repair: a combination of two drugs (dexmedetomidine and ketamine) given through a nebulizer versus dexmedetomidine alone. The goal is to see which approach works better for calming the child before surgery and preventing confusion or agitation after waking up. The study will involve 60 children aged 1-6 years who are scheduled for this surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Oct 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 48 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries Exclusion Criteria: * Parent refusal * Allergy to the study drugs * Suspected difficult airway * Patients with endocrine, renal, hepatic, and cardiac pathology * Psychiatric diseases * Asthmatic patients.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assiut University
RECRUITINGAsyut, 71515, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a safer opioid choice stop Kids' Post-Surgery agitation?
- Could a sleep hormone stop Children's Post-Surgery delirium?
- Can a gentle oxygen boost make lung biopsies safer and faster?
- Can a single injection calm infants waking from anesthesia?
- A Mother's voice as medicine? trial tests comforting effect on ventilated children