Clinical trial NCT05192629 - References

Dexmedetomidine — Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging

Citation(s)

•   Anttila M, Penttilä J, Helminen A, Vuorilehto L, Scheinin H
  Bioavailability of dexmedetomidine after extravascular doses in healthy subjects. Br J Clin Pharmacol. 2003 Dec;56(6):691-3.
•   Berkenbosch JW
  Options and Considerations for Procedural Sedation in Pediatric Imaging. Paediatr Drugs. 2015 Oct;17(5):385-99. doi: 10.1007/s40272-015-0140-6. Review.
•   Bhatt M, Kennedy RM, Osmond MH, Krauss B, McAllister JD, Ansermino JM, Evered LM, Roback MG; Consensus Panel on Sedation Research of Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN)
  Consensus-based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2009 Apr;53(4):426-435.e4. doi: 10.1016/j.annemergmed.2008.09.030. Epub 2008 Nov 20.
•   Cho JE, Kim WO, Chang DJ, Choi EM, Oh SY, Kil HK
  Titrated propofol induction vs. continuous infusion in children undergoing magnetic resonance imaging. Acta Anaesthesiol Scand. 2010 Apr;54(4):453-7. doi: 10.1111/j.1399-6576.2009.02169.x. Epub 2009 Nov 23.
•   Chorney JM, Kain ZN
  Behavioral analysis of children's response to induction of anesthesia. Anesth Analg. 2009 Nov;109(5):1434-40. doi: 10.1213/ane.0b013e3181b412cf. Epub 2009 Aug 27.
•   Coté CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY
  Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1). pii: e20161212. doi: 10.1542/peds.2016-1212.
•   Ghai B, Jain K, Saxena AK, Bhatia N, Sodhi KS
  Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr Anaesth. 2017 Jan;27(1):37-44. doi: 10.1111/pan.13010. Epub 2016 Oct 13.
•   Gupta A, Dalvi NP, Tendolkar BA
  Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients: A prospective randomized double blind trial. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):236-240. doi: 10.4103/joacp.JOACP_204_16.
•   Gutmann A, Pessenbacher K, Gschanes A, Eggenreich U, Wargenau M, Toller W
  Propofol anesthesia in spontaneously breathing children undergoing magnetic resonance imaging: comparison of two propofol emulsions. Paediatr Anaesth. 2006 Mar;16(3):266-74.
•   Jun JH, Kim KN, Kim JY, Song SM
  The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth. 2017 Sep;64(9):947-961. doi: 10.1007/s12630-017-0917-x. Epub 2017 Jun 21. Review.
•   Jung SM
  Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging. Yeungnam Univ J Med. 2020 Jul;37(3):159-168. doi: 10.12701/yujm.2020.00171. Epub 2020 Apr 17.
•   Kim HJ, Shin WJ, Park S, Ahn HS, Oh JH
  The sedative effects of the intranasal administration of dexmedetomidine in children undergoing surgeries compared to other sedation methods: A systematic review and meta-analysis. J Clin Anesth. 2017 May;38:33-39. doi: 10.1016/j.jclinane.2017.01.014. Epub 2017 Jan 15. Review.
•   Kumar L, Kumar A, Panikkaveetil R, Vasu BK, Rajan S, Nair SG
  Efficacy of intranasal dexmedetomidine versus oral midazolam for paediatric premedication. Indian J Anaesth. 2017 Feb;61(2):125-130. doi: 10.4103/0019-5049.199850.
•   Leroy PL, Costa LR, Emmanouil D, van Beukering A, Franck LS
  Beyond the drugs: nonpharmacologic strategies to optimize procedural care in children. Curr Opin Anaesthesiol. 2016 Mar;29 Suppl 1:S1-13. doi: 10.1097/ACO.0000000000000312. Review.
•   Li BL, Zhang N, Huang JX, Qiu QQ, Tian H, Ni J, Song XR, Yuen VM, Irwin MG
  A comparison of intranasal dexmedetomidine for sedation in children administered either by atomiser or by drops. Anaesthesia. 2016 May;71(5):522-8. doi: 10.1111/anae.13407. Epub 2016 Mar 3.
•   Mahmoud M, Barbi E, Mason KP
  Dexmedetomidine: What's New for Pediatrics? A Narrative Review. J Clin Med. 2020 Aug 24;9(9). pii: E2724. doi: 10.3390/jcm9092724. Review.
•   Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N
  Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS). Br J Anaesth. 2002 Feb;88(2):241-5.
•   Mason KP, Park RS, Sullivan CA, Lukovits K, Halpin EM, Imbrescia ST, Cavanaugh D, Prescilla R, Fox VL
  The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial. Eur J Anaesthesiol. 2021 May 1;38(5):541-547. doi: 10.1097/EJA.0000000000001350.
•   Mason KP
  Sedation trends in the 21st century: the transition to dexmedetomidine for radiological imaging studies. Paediatr Anaesth. 2010 Mar;20(3):265-72. doi: 10.1111/j.1460-9592.2009.03224.x. Epub 2009 Dec 10. Review.
•   Mekitarian Filho E, Robinson F, de Carvalho WB, Gilio AE, Mason KP
  Intranasal dexmedetomidine for sedation for pediatric computed tomography imaging. J Pediatr. 2015 May;166(5):1313-1315.e1. doi: 10.1016/j.jpeds.2015.01.036. Epub 2015 Mar 6.
•   Nagoshi M, Reddy S, Bell M, Cresencia A, Margolis R, Wetzel R, Ross P
  Low-dose dexmedetomidine as an adjuvant to propofol infusion for children in MRI: A double-cohort study. Paediatr Anaesth. 2018 Jul;28(7):639-646. doi: 10.1111/pan.13400. Epub 2018 Jun 7.
•   Peng K, Wu SR, Ji FH, Li J
  Premedication with dexmedetomidine in pediatric patients: a systematic review and meta-analysis. Clinics (Sao Paulo). 2014 Nov;69(11):777-86. doi: 10.6061/clinics/2014(11)12. Review.
•   Petroz GC, Sikich N, James M, van Dyk H, Shafer SL, Schily M, Lerman J
  A phase I, two-center study of the pharmacokinetics and pharmacodynamics of dexmedetomidine in children. Anesthesiology. 2006 Dec;105(6):1098-110.
•   Radhika KP, Sreejit MS, Ramadas KT
  Efficacy of midazolam as oral premedication in children in comparison to triclofos sodium. Indian J Anaesth. 2016 Jun;60(6):415-9. doi: 10.4103/0019-5049.183389.
•   Rosen DA, Daume JT
  Short duration large dose dexmedetomidine in a pediatric patient during procedural sedation. Anesth Analg. 2006 Jul;103(1):68-9, table of contents.
•   Sadeghi A, Khaleghnejad Tabari A, Mahdavi A, Salarian S, Razavi SS
  Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents: a randomized clinical trial. Neuropsychiatr Dis Treat. 2017 Feb 20;12:3237-3241. doi: 10.2147/NDT.S119208. eCollection 2017.
•   Sriganesh K, Saini J, Theerth K, Venkataramaiah S
  Airway Dimensions in Children with Neurological Disabilities During Dexmedetomidine and Propofol Sedation for Magnetic Resonance Imaging Study. Turk J Anaesthesiol Reanim. 2018 Jun;46(3):214-221. doi: 10.5152/TJAR.2017.48285. Epub 2017 Nov 27.
•   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.
•   Sun Y, Lu Y, Huang Y, Jiang H
  Is dexmedetomidine superior to midazolam as a premedication in children? A meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Aug;24(8):863-74. doi: 10.1111/pan.12391. Epub 2014 Mar 26.
•   Talon MD, Woodson LC, Sherwood ER, Aarsland A, McRae L, Benham T
  Intranasal dexmedetomidine premedication is comparable with midazolam in burn children undergoing reconstructive surgery. J Burn Care Res. 2009 Jul-Aug;30(4):599-605. doi: 10.1097/BCR.0b013e3181abff90.
•   Tu Y, Liang Y, Xiao Y, Lv J, Guan R, Xiao F, Xie Y, Xiao Q
  Dexmedetomidine attenuates the neurotoxicity of propofol toward primary hippocampal neurons in vitro via Erk1/2/CREB/BDNF signaling pathways. Drug Des Devel Ther. 2019 Feb 19;13:695-706. doi: 10.2147/DDDT.S188436. eCollection 2019.
•   van Hoorn CE, Flint RB, Skowno J, Davies P, Engelhardt T, Lalwani K, Olutoye O, Ista E, de Graaff JC
  Off-label use of dexmedetomidine in paediatric anaesthesiology: an international survey of 791 (paediatric) anaesthesiologists. Eur J Clin Pharmacol. 2021 Apr;77(4):625-635. doi: 10.1007/s00228-020-03028-2. Epub 2020 Oct 29.
•   Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F
  Predictors of preoperative anxiety in children. Anaesth Intensive Care. 2003 Feb;31(1):69-74.
•   Yip P, Middleton P, Cyna AM, Carlyle AV
  Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006447. doi: 10.1002/14651858.CD006447.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD006447.

Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Phase 3 Clinical Trial Comparing the Safety and Efficacy of Intranasal Dexmedetomidine to Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging

Details for clinical trial NCT05192629