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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02361476 |
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Date of registration:
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01/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
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Scientific title:
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Does Intraoperative Clonidine Reduce Post Operative Agitation in Children Anaesthetised With Sevoflurane? A RCT Including Pharmacokinetic Investigation. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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379 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02361476 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Steen Henneberg, MD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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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.
Age minimum:
1 Year
Age maximum:
5 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psychomotor Agitation
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Intervention(s)
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Drug: Clonidine
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Drug: Placebo
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Primary Outcome(s)
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Postoperative Agitation
[Time Frame: 1 day]
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Secondary Outcome(s)
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Pain Assessment
[Time Frame: recovery room - hours]
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Adverse Events
[Time Frame: from intervention to discharge from the recovery room]
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First Administration of Fentanyl or Morphine
[Time Frame: recovery room]
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Fentanyl and Morphine Requirements
[Time Frame: Recorded during the stay in the postoperative recovery room]
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Secondary ID(s)
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H - 2 - 2014 - 072
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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