Nasal spray could replace needles for Pre-Surgery anxiety in toddlers
NCT ID NCT03725930
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested whether a clonidine nasal spray can calm young children (ages 1-5) before minor surgery. Researchers compared it to a placebo spray in 90 kids. The goal was to see if the spray reduces anxiety and helps children accept the anesthesia mask more easily.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clonidine nasal spray
- What this could lead to
- If it works, this could provide a needle-free way to reduce anxiety in young children before surgery.
- What could go wrong
- This is a small, completed Phase 3 trial with only 90 participants, so results may not apply to all children. Clonidine can cause side effects like low blood pressure or drowsiness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
90 people
The number who actually took part.
- Started
-
Mar 2019
- Finished
-
Nov 2023
- Lead sponsor
-
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
-
1 year to 5 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Child from 1 to 5 years 2. Weight between 10 to 25 kgs 3. Scheduled minor surgery 4. Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s). 5. ASA score 1 or 2 6. Patient with social care insurance Exclusion Criteria: 1. Refusal of one of the parental authority or legal representing 2. Concomitant participation to a clinical trial with use of a drug 3. Known hypersensitivity or contraindication to Clonidine or one of its excipients 4. Airway infection within 3 weeks before inclusion 5. Intravenous induction of anesthesia 6. Antecedent of arrhythmia or congenital heart disease 7. Mental disorder or current psychoactive medication
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHRU Lille
Lille, Nord, 59000, France
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