Child PreschoolPhase 3CLONIPREMNCT03725930
Premedication by Clonidine Intranasal in Pediatric Surgery
A Phase 3 study testing Clonidine in people with Child Preschool, run by University Hospital, Lille at 1 site in France.
Trial summary
There are few studies using intra nasal way to dispense premedication in pediatrics. This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Preschool
- What is being tested?
- Clonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2019to 24 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child from 1 to 5 years
- Weight between 10 to 25 kgs
- Scheduled minor surgery
- Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s).
- ASA score 1 or 2
- Patient with social care insurance
Who cannot join
- Refusal of one of the parental authority or legal representing
- Concomitant participation to a clinical trial with use of a drug
- Known hypersensitivity or contraindication to Clonidine or one of its excipients
- Airway infection within 3 weeks before inclusion
- Intravenous induction of anesthesia
- Antecedent of arrhythmia or congenital heart disease
- Mental disorder or current psychoactive medication
Trial locations and contacts
1 site in 1 country.
About this study
There are few studies using intra nasal way to dispense premedication in pediatrics.
This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.
Two groups, randomized,
Total of 150 patients (75 in each group) :
Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)
- Conditions
- Child Preschool
- Being tested
- Clonidine, Placebo
- Keywords
- paediatric, premedication, clonidine, intranasal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
clonidine intranasal premedication in preschool infants
PlaceboOther
Placebo intranasal premedication
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Active comparator | This arm will receive intra nasal Clonidine as a premedication before surgery Receives: Drug: Clonidine |
| Placebo | Placebo comparator | This arm will receive intra nasal Placebo as a premedication before surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiolysis score
Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative
Measured: at 30 minutes after premedication
Secondary outcomes (2)
Acceptation of mask at the induction of anesthesia
Yes / No
Measured: 1 hour after premedication
Agitation score after the extubation
Agitation score : 0 : Patient
Measured: 15 min after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start26 Mar 2019
- Primary completion24 Nov 2021
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child PreschoolStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dina BERT, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725930
- Sponsor's protocol ID
- 2016_37
- Other IDs
- 2017-003638-10, 2017
- Acronym
- CLONIPREM
- Status last verified
- Dec 2025
- First submitted
- 29 Oct 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication by Clonidine Intranasal in Pediatric Surgery
- ClinicalTrials.gov ID
- NCT03725930
- Acronym / sponsor ID
- CLONIPREM / 2016_37
- Conditions
- Child Preschool
- Keywords
- paediatric, premedication, clonidine, intranasal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are few studies using intra nasal way to dispense premedication in pediatrics.
This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.
Two groups, randomized,
Total of 150 patients (75 in each group) :
Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Active comparator | Drug: ClonidineThis arm will receive intra nasal Clonidine as a premedication before surgery |
| Placebo | Placebo comparator | Other: PlaceboThis arm will receive intra nasal Placebo as a premedication before surgery |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child from 1 to 5 years
- Weight between 10 to 25 kgs
- Scheduled minor surgery
- Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s).
- ASA score 1 or 2
Key exclusion criteria (7 listed)
- Refusal of one of the parental authority or legal representing
- Concomitant participation to a clinical trial with use of a drug
- Known hypersensitivity or contraindication to Clonidine or one of its excipients
- Airway infection within 3 weeks before inclusion
- Intravenous induction of anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidineclonidine intranasal premedication in preschool infants | Drug | Clonidine |
| PlaceboPlacebo intranasal premedication | Other | Placebo |
Primary outcome
Anxiolysis score
Time frame: at 30 minutes after premedication
Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative
2 secondary outcomes
Acceptation of mask at the induction of anesthesia
Time frame: 1 hour after premedication
Agitation score after the extubation
Time frame: 15 min after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina BERT, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clonidine in people with Child Preschool, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiolysis score (time frame: at 30 minutes after premedication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.