Clinical trial NCT04820205: Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
Official title: Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Keywords: pediatric
procedural sedation
chloral hydrate
intranasal dexmedetomidine
intranasal ketamine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 136
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the first-attempt success rate of pediatric procedural sedation. The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of adequate pediatric procedural sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients undergoing procedural sedation. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).


Eligibility criteria: Inclusion Criteria:

* Pediatric patients who need procedural sedation (Age \< 7 years)
* ASA (American Society of Anesthesiologists) physical status 1-3

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status 4-5
* History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate
* Recent administration of Alpha 2 adrenergic receptor agonist or antagonist
* Cannot administrate oral medication (e.g. Swallowing difficulty)
* Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)
* Unstable vital signs, Unstable arrhythmia

Primary outcomes:
measure: Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes %
timeFrame: During pediatric procedural sedation (up to 1 hour)
Secondary outcomes:
measure: Onset time of sedation (PSSS= 0,1,2,3) (min)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Duration of sedation = Recovery time (PSSS= 4,5) (min)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: PSSS(Pediatric Sedation State Scale, 0-5)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Heart rate during sedation (/min)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: SpO2 during sedation (%)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Respiratory rate during sedation (/min)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of respiratory intervention: Manual ventilation or Artificial airway %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of significant apnea (>20seconds) %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The lowest SpO2 value (%)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of hemodynamic intervention: fluid management, intravenous medication %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of significant bradycardia (-30% from baseline) %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of significant hypotension (-30% from baseline) %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min %
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: The incidence of completion of procedure
timeFrame: During pediatric procedural sedation (up to 3 hour)
measure: Total cost of sedation (KRW), optional
timeFrame: During pediatric procedural sedation (up to 1 day)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
citation: Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.
citation: Cao Q, Lin Y, Xie Z, Shen W, Chen Y, Gan X, Liu Y. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth. 2017 Jun;27(6):629-636. doi: 10.1111/pan.13148. Epub 2017 Apr 17.
citation: Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
citation: Zanaty OM, El Metainy SA. A comparative evaluation of nebulized dexmedetomidine, nebulized ketamine, and their combination as premedication for outpatient pediatric dental surgery. Anesth Analg. 2015 Jul;121(1):167-171. doi: 10.1213/ANE.0000000000000728.
citation: Zhang W, Fan Y, Zhao T, Chen J, Zhang G, Song X. Median Effective Dose of Intranasal Dexmedetomidine for Rescue Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging. Anesthesiology. 2016 Dec;125(6):1130-1135. doi: 10.1097/ALN.0000000000001353.
citation: 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.
citation: Abdel-Ghaffar HS, Kamal SM, El Sherif FA, Mohamed SA. Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy. Br J Anaesth. 2018 Aug;121(2):445-452. doi: 10.1016/j.bja.2018.03.039. Epub 2018 Jun 22.
citation: Poonai N, Canton K, Ali S, Hendrikx S, Shah A, Miller M, Joubert G, Rieder M, Hartling L. Intranasal ketamine for procedural sedation and analgesia in children: A systematic review. PLoS One. 2017 Mar 20;12(3):e0173253. doi: 10.1371/journal.pone.0173253. eCollection 2017.