Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children
Study Details
Study Description
Brief Summary
This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dexmedetomidine Intravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit |
Drug: Dexmedetomidine Hydrochloride
Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Plasma concentration of dexmedetomidine [From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion]
Plasma concentration of dexmedetomidine before infusion, 10/30/60 minutes after initiation of infusion, 15/30/60/120/240/480 minutes after end of infusion
- Bispectral index [From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion]
Bispectral index based on electroencephalogram during patient's stay at intensive care unit (0-100, lower score implies deeper sedation)
- University of Michigan Sedation Scale [From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion]
University of Michigan Sedation Scale based on observer's inspection during patient's stay at intensive care unit (0-4, higher score implies deeper sedation)
Secondary Outcome Measures
- Incidence of arrhythmia [From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion]
Presence of any kind of arrhythmia from electrocardiogram following dexmedetomidine infusion
- Non-invasive blood pressure [From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion]
Non-invasive blood pressure in units of mmHg, to examine whether hypertension (increase in blood pressure more than 20% of baseline) or hypotension (decrease in blood pressure more than 20% of baseline) occurs
- Incidence of desaturation [From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion]
Presence of desaturation (pulse oximetry of lower than 94%) following dexmedetomidine infusion
- Respiratory rate [From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion]
Respiratory rate in units of /min, to examine whether respiratory depression or apnea occurs
- Incidence of nausea [From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion]
Incidence of nausea following dexmedetomidine infusion
- Incidence of vomiting [From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion]
Incidence of vomiting following dexmedetomidine infusion
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery
-
Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination
-
Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study.
Exclusion Criteria:
-
History of hypersensitivity to any drugs including dexmedetomidine.
-
Underlying cardiovascular/circulatory disease
-
Underlying liver / kidney disease
-
Patients under hemodialysis
-
Obesity of BMI > 35
-
Patients planned to receive patient-controlled analgesia including opioids
-
Patients whose parent or legal guardian declined to enroll in the study
-
Other conditions deemed unsuitable for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Jongro Gu | Korea, Republic of | 03080 |
Sponsors and Collaborators
- Seoul National University Hospital
- Ministry of Food and Drug Safety, Korea
Investigators
- Principal Investigator: Hee-Soo Kim, M.D., Ph.D., Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Banasch HL, Dersch-Mills DA, Boulter LL, Gilfoyle E. Dexmedetomidine Use in a Pediatric Intensive Care Unit: A Retrospective Cohort Study. Ann Pharmacother. 2018 Feb;52(2):133-139. doi: 10.1177/1060028017734560. Epub 2017 Sep 27.
- Berkenbosch JW, Wankum PC, Tobias JD. Prospective evaluation of dexmedetomidine for noninvasive procedural sedation in children. Pediatr Crit Care Med. 2005 Jul;6(4):435-9; quiz 440.
- Chrysostomou C, Sanchez De Toledo J, Avolio T, Motoa MV, Berry D, Morell VO, Orr R, Munoz R. Dexmedetomidine use in a pediatric cardiac intensive care unit: can we use it in infants after cardiac surgery? Pediatr Crit Care Med. 2009 Nov;10(6):654-60. doi: 10.1097/PCC.0b013e3181a00b7a. Erratum in: Pediatr Crit Care Med. 2012 May;13(3):373.
- Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.
- Díaz SM, Rodarte A, Foley J, Capparelli EV. Pharmacokinetics of dexmedetomidine in postsurgical pediatric intensive care unit patients: preliminary study. Pediatr Crit Care Med. 2007 Sep;8(5):419-24.
- Kim HS, Byon HJ, Kim JE, Park YH, Lee JH, Kim JT. Appropriate dose of dexmedetomidine for the prevention of emergence agitation after desflurane anesthesia for tonsillectomy or adenoidectomy in children: up and down sequential allocation. BMC Anesthesiol. 2015 May 27;15:79. doi: 10.1186/s12871-015-0059-z.
- Koroglu A, Demirbilek S, Teksan H, Sagir O, But AK, Ersoy MO. Sedative, haemodynamic and respiratory effects of dexmedetomidine in children undergoing magnetic resonance imaging examination: preliminary results. Br J Anaesth. 2005 Jun;94(6):821-4. Epub 2005 Mar 11.
- Mahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015 Aug;115(2):171-82. doi: 10.1093/bja/aev226. Review.
- Plambech MZ, Afshari A. Dexmedetomidine in the pediatric population: a review. Minerva Anestesiol. 2015 Mar;81(3):320-32. Epub 2014 May 14. Review.
- Reiter PD, Pietras M, Dobyns EL. Prolonged dexmedetomidine infusions in critically ill infants and children. Indian Pediatr. 2009 Sep;46(9):767-73. Epub 2009 Apr 1.
- Su F, Hammer GB. Dexmedetomidine: pediatric pharmacology, clinical uses and safety. Expert Opin Drug Saf. 2011 Jan;10(1):55-66. doi: 10.1517/14740338.2010.512609. Epub 2010 Aug 18. Review.
- Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11.
- Tobias JD, Berkenbosch JW. Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J. 2004 May;97(5):451-5.
- Tobias JD. Dexmedetomidine: applications in pediatric critical care and pediatric anesthesiology. Pediatr Crit Care Med. 2007 Mar;8(2):115-31. Review.
- Walker J, Maccallum M, Fischer C, Kopcha R, Saylors R, McCall J. Sedation using dexmedetomidine in pediatric burn patients. J Burn Care Res. 2006 Mar-Apr;27(2):206-10.
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