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
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|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||379 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Clonidine : injection og 3 micg/kg IV during the operation.
Injection - during surgery
Other Name: catapresan
Placebo Comparator: Placebo
Placebo : injection og equal amount of NaCl IV during the operation.
Injection - during surgery
Other Name: NaCl
- Postoperative Agitation [ Time Frame: 1 day ]Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated
- Fentanyl and Morphine Requirements [ Time Frame: Recorded during the stay in the postoperative recovery room ]Amount used
- 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
- First Administration of Fentanyl or Morphine [ Time Frame: recovery room ]Time to administration
- Adverse Events [ Time Frame: from intervention to discharge from the recovery room ]
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
|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|
|Study Director:||Steen Henneberg, MD, DMSc||Rigshospitalet, Denmark|