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Trial record 52 of 326 for:    clonidine

Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

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ClinicalTrials.gov Identifier: NCT02361476
Recruitment Status : Completed
First Posted : February 11, 2015
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mogens Ydemann, Rigshospitalet, Denmark

Brief Summary:

Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.

In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.


Condition or disease Intervention/treatment Phase
Psychomotor Agitation Drug: Clonidine Drug: Placebo Phase 4

Detailed Description:

BACKGROUND:

Clonidine is widely used off-label in children for several indications such as treatment and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However, the current level of evidence in support of Clonidine treatment for postoperative agitation in children remains limited. In addition, the pharmacokinetic profile of intravenous Clonidine in children is not well characterized for age-groups.

METHODS/DESIGN:

In this prospective multicentre double-blinded randomized clinical trial, the investigators aim to investigate the impact of intravenous (IV) Clonidine administered at the end of surgery, on the incidence and degree of postoperative agitation. Children will be assigned to either the intervention or the placebo group. The allocation will be carried out centrally and stratified based on age and trial-site, with152 patients allocated to each group. In the intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20 minutes before the expected completion of the surgery (as assessed by the surgeon). In the control group; Saline (placebo) is injected in equal quantity during surgery at the same time. The drugs are concealed in identical blinded ampoules.

The primary outcome is postoperative agitation measured on the Watcha scale. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including 30-day follow-up.

Twenty of the patients age 1-2 years and twenty age >2 years, with a peripheral venous access in place, will be allocated to drug assay sampling; enabling a compartmental PK analysis based on age group, using non-linear mixed effects models.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Intraoperative Clonidine Reduce Post Operative Agitation in Children Anaesthetised With Sevoflurane? A RCT Including Pharmacokinetic Investigation.
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Clonidine : injection og 3 micg/kg IV during the operation.
Drug: Clonidine
Injection - during surgery
Other Name: catapresan

Placebo Comparator: Placebo
Placebo : injection og equal amount of NaCl IV during the operation.
Drug: Placebo
Injection - during surgery
Other Name: NaCl




Primary Outcome Measures :
  1. Postoperative Agitation [ Time Frame: 1 day ]
    Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated


Secondary Outcome Measures :
  1. Fentanyl and Morphine Requirements [ Time Frame: Recorded during the stay in the postoperative recovery room ]
    Amount used

  2. Pain Assessment [ Time Frame: recovery room - hours ]

    Pain score used:

    FLACC score = Face, Legs, Activity, Cry, Consolability Score ranges from 0 to 10 (severity increases with increasing score) Pain is FLACC score more than 3


  3. First Administration of Fentanyl or Morphine [ Time Frame: recovery room ]
    Time to administration

  4. Adverse Events [ Time Frame: from intervention to discharge from the recovery room ]


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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for surgery with Sevoflurane as the choice of anesthesia.

Exclusion Criteria:

  • ASA classification >2
  • Premedication with Clonidine
  • Ex-premature (born before week 37+0 AND <60 weeks old)
  • Intubated before anaesthesia and/or no plans for extubation after anaesthesia.
  • Critical illness with haemodynamic instability.
  • Active bleeding.
  • Cancer.
  • Cardiac diseases including arrhythmias.
  • Malignant hyperthermia.
  • Mental retardation.
  • Neurological illness with agitation-like symptoms.
  • Weight >50 kg.
  • Allergy to Clonidine.
  • Patients treated with methylphenidate / Concerta.

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): NCT02361476


Locations
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Denmark
The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Zealand, Denmark, 2100
Køge Sygehus, Anæstesiologisk Afdeling
Køge, Denmark, 4600
Anæstesiologisk afdeling, Vejle Sygehus
Vejle, Denmark, 7100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Director: Steen Henneberg, MD, DMSc Rigshospitalet, Denmark

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mogens Ydemann, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02361476     History of Changes
Other Study ID Numbers: H - 2 - 2014 - 072
First Posted: February 11, 2015    Key Record Dates
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019
Last Verified: September 2018
Keywords provided by Mogens Ydemann, Rigshospitalet, Denmark:
Anaesthesia
Children
Clonidine
Sevoflurane
Postoperative agitation
Prevention
Pharmacokinetics
Safety
Additional relevant MeSH terms:
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Clonidine
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action