Nasal spray could replace needles for Pre-Surgery anxiety in toddlers

NCT ID NCT03725930

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Child, preschool are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.