Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 326 for:    clonidine

Premedication by Clonidine Intranasal in Pediatric Surgery (CLONIPREM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725930
Recruitment Status : Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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.

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)


Condition or disease Intervention/treatment Phase
Child Preschool Drug: Clonidine Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Premedication by Clonidine Intranasal in Pediatric Surgery
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clonidine
This arm will receive intra nasal Clonidine as a premedication before surgery
Drug: Clonidine
clonidine intranasal premedication in preschool infants

Placebo Comparator: Placebo
This arm will receive intra nasal Placebo as a premedication before surgery
Other: Placebo
Placebo intranasal premedication




Primary Outcome Measures :
  1. Anxiolysis score [ Time Frame: at 30 minutes after premedication ]
    Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative


Secondary Outcome Measures :
  1. Acceptation of mask at the induction of anesthesia [ Time Frame: 1 hour after premedication ]
    Yes / No

  2. Agitation score after the extubation [ Time Frame: 15 min after extubation ]
    Agitation score : 0 : Patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725930


Contacts
Layout table for location contacts
Contact: Dina BERT, MD 3 20 44 60 69 ext +33 dina.bert@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Dina BERT, MD University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03725930     History of Changes
Other Study ID Numbers: 2016_37
2017-003638-10 ( EudraCT Number )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
paediatric
premedication
clonidine
intranasal
Additional relevant MeSH terms:
Layout table for MeSH terms
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action