A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children

• ClinicalTrials.gov Identifier: NCT02459509
• Recruitment Status: Unknown
• First Posted: June 2, 2015
• Last Update Posted: April 18, 2016
• Sponsor: The University of Hong Kong
• Information provided by (Responsible Party): The University of Hong Kong

Tracking Information

• First Submitted Date: May 20, 2015
• First Posted Date: June 2, 2015
• Last Update Posted Date: April 18, 2016
• Study Start Date: June 2015
• Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 28, 2015)

Satisfactory sedation [ Time Frame: From 30 minutes post drug administration to induction of anaesthesia (average 30 minutes) ]

The primary outcome will be the proportion of children with satisfactory sedation at the time of anaesthesic induction.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 28, 2015)

• Time to satisfactory sedation [ Time Frame: From time of drug administration to when Observer's Assessment of Alertness/ Sedation Score is 2 or less (from 0 minutes to 30 minutes) ]
  Time taken from drug administration to when the child's sedation level is that of only responding after mild prodding or shaking
• Blood pressure [ Time Frame: From drug administration to end of anaesthesia (on average 1 to 3 hours) ]
  Blood pressure will be taken every 5 minutes
• Heart rate [ Time Frame: From drug administration to end of anaesthesia (on average 1 to 3 hours) ]
  Heart rate will be taken every 5 minutes
• Oxygen saturations [ Time Frame: From drug administration to end of anaesthesia (on average 1 to 3 hours) ]
  Oxygen saturations will be taken every 5 minutes

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children
• Official Title: A Comparison of Two Doses of Intranasal Dexmedetomidine for Premedication in Children - a Double- Blind Randomised Controlled Trial
• Brief Summary: The purpose of the study is to determine if 4mcg/kg of intranasal dexmedetomidine is better than 2mcg/kg in successfully sedating a child prior to induction of anesthesia.

Detailed Description

Dexmedetomidine is a selective alpha-2 adrenoreceptor agonist that has sedative, anxiolytic and analgesic properties without causing respiratory depression. It has been administered safely and effectively via a number of routes including as an intravenous infusion, intramuscularly, intranasally, buccally and orally .

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Anxiety, Separation

Intervention

Drug: Dexmedetomidine

Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation

Other Name: Precedex

Study Arms

• Active Comparator: Dexmedetomidine 2 mcg/kg
  2 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
  Intervention: Drug: Dexmedetomidine
• Active Comparator: Dexmedetomidine 4 mcg/kg
  4 mcg/kg dexmedetomidine given intranasally once at least 30 minutes before anaesthetic induction
  Intervention: Drug: Dexmedetomidine

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 28, 2015): 140
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2016
• Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• All children of American Society of Anesthesiologists (ASA) physical status classification I or II (healthy) between the ages of 6 months and 5 years undergoing surgery at Queen Mary Hospital

Exclusion Criteria:

• Any patient receiving other sedative premedication, allergy to dexmedetomidine, organ dysfunction, cardiac arrhythmia and congenital heart disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 5 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT02459509
• Other Study ID Numbers: UW 15-105
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: The University of Hong Kong
• Study Sponsor: The University of Hong Kong
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sophie E Liu, MBBS; Hong Kong University

• PRS Account: The University of Hong Kong
• Verification Date: April 2016