A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children
NCT ID: NCT02459509
Last Updated: 2016-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
140 participants
INTERVENTIONAL
2015-06-30
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children
NCT01065701
Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.
NCT07180095
Determining the Pharmacogenetic Basis of Non-responsiveness to the Sedative Effects of Dexmedetomidine in Children
NCT04471402
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
NCT06853431
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
NCT02836431
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Yuen et al established that the median time of onset of sedation is 25-30 minutes, making it an ideal agent for preoperative sedation. The same group also studied doses of 1 mcg/kg and 2 mcg/kg as a sedative premedication and found that the success rates of appropriate sedation at induction in children aged 1 to 8 years were 53% and 66% respectively, with a dose related increase in successful sedation.
Much higher doses of dexmedetomidine have also been used safely. Administered intravenously, 3mcg/kg of dexmedetomidine has been shown to provide satisfactory sedation for paediatric MRI in 97% of cases, without adverse effects.
The investigators aim to show that high dose intranasal dexmedetomidine is a safe, effective and an easily administered sedative premedication.
The investigators hypothesise that 4mcg/kg compared to 2mcg/kg of intranasal dexmedetomidine will lead to at least a 20% increase in the proportion of satisfactorily sedated patients at the time of anaesthesia induction.
The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesia induction.
Suitable patients will be identified from the theatre lists and consent will be sought from their legal guardians during preassessment clinic or during their anaesthetic preoperative assessment on the ward.
In a previous study, 66% of children aged 1-5 years were satisfactorily sedated at the time of induction with 2 mcg/kg of intranasal dexmedetomidine. In order to find a 20% difference with 4 mcg/kg of dexmedetomidine, the investigators' sample size needs to be 140 (70 in each group), for a power of 0.8 and a 5% false positive rate.
The demographic data will be analysed by t test and chi-square test. The proportions of satisfactory sedation will be analysed by chi-square test. The onset sedation time and duration of sedation will be analysed by survival analysis. The vital signs over times will be expressed by percentage changes from baseline and estimated by mean and standard errors. A p-value\<0.05 will be considered statistically significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexmedetomidine 2 mcg/kg
2 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
Dexmedetomidine
Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Dexmedetomidine 4 mcg/kg
4 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
Dexmedetomidine
Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine
Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
6 Months
5 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sophie E Liu, MBBS
Role: PRINCIPAL_INVESTIGATOR
Hong Kong University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Pestieau SR, Quezado ZM, Johnson YJ, Anderson JL, Cheng YI, McCarter RJ, Choi S, Finkel JC. High-dose dexmedetomidine increases the opioid-free interval and decreases opioid requirement after tonsillectomy in children. Can J Anaesth. 2011 Jun;58(6):540-50. doi: 10.1007/s12630-011-9493-7. Epub 2011 Apr 2.
Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.
Mason KP, Lubisch NB, Robinson F, Roskos R. Intramuscular dexmedetomidine sedation for pediatric MRI and CT. AJR Am J Roentgenol. 2011 Sep;197(3):720-5. doi: 10.2214/AJR.10.6134.
Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UW 15-105
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.