Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation

Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation: a Randomized Controlled Trial

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 success rate of rescue sedation after failed sedation (PSSS=4,5) with chloral hydrate (50mg/kg) The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of rescue 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 after failed sedation attempt with oral chloral hydrate. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).

Study Overview

• Status: Not yet recruiting
• Conditions: Sedation
• Intervention / Treatment: Drug: Intranasal dexmedetomidine and ketamine; Drug: Oral chloral hydrate

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin-Tae Kim, MD. PhD; Phone Number: 82-2-2072-3664; Email: jintae73@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pediatric patients who need procedural sedation (Age < 7 years)
• ASA (American Society of Anesthesiologists) physical status 1-3
• Failed to induce sedation with oral chloral hydrate 50mg/kg

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intranasal dexmedetomdine and kemtaine; Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)	Drug: Intranasal dexmedetomidine and ketamine; Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)
Active Comparator: oral chloral hydrate; Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)	Drug: Oral chloral hydrate; Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of adequate rescue sedation (PSSS = 1, 2, 3) within 15 minutes %	Success rate of adequate rescue sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %	During pediatric procedural sedation (up to 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSSS(Pediatric Sedation State Scale, 0-5)	5 Patient is moving in a manner that impedes the proceduralist and requires forceful immobilization. 4 Moving during the procedure that requires gentle immobilization for positioning. 3 Expression of pain or anxiety on face, but not moving or impeding completion of the procedure. 2 Quiet (asleep or awake), not moving during procedure, and no frown (or brow furrow) indicating pain or anxiety. 1 Deeply asleep with normal vital signs, but requiring airway intervention and/or assistance 0 Sedation associated with abnormal physiologic parameters that require acute intervention q 10min	During pediatric procedural sedation (up to 3 hour)
SpO2 during sedation (%)	SpO2(%) by pulse oximetry at Baseline(T0), q 10min	During pediatric procedural sedation (up to 3 hour)
Respiratory rate during sedation (/min)	RR(/min) at Baseline(T0), q 10min	During pediatric procedural sedation (up to 3 hour)
the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %	the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %	During pediatric procedural sedation (up to 3 hour)
The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %	The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) %	During pediatric procedural sedation (up to 3 hour)
The incidence of significant apnea (>20seconds) %	The incidence of significant apnea (>20seconds) %	During pediatric procedural sedation (up to 3 hour)
The lowest SpO2 value (%)	The lowest SpO2 value (%)	During pediatric procedural sedation (up to 3 hour)
The incidence of hemodynamic intervention: fluid management, intravenous medication %	The incidence of hemodynamic intervention: fluid management, intravenous medication %	During pediatric procedural sedation (up to 3 hour)
The incidence of significant bradycardia (-30% from baseline) %	The incidence of significant bradycardia (-30% from baseline) %	During pediatric procedural sedation (up to 3 hour)
The incidence of significant hypotension (-30% from baseline) %	The incidence of significant hypotension (-30% from baseline) %	During pediatric procedural sedation (up to 3 hour)
Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)	Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)	During pediatric procedural sedation (up to 3 hour)
Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)	Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)	During pediatric procedural sedation (up to 3 hour)
Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)	Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)	During pediatric procedural sedation (up to 3 hour)
Total cost of sedation (KRW)	Total cost of sedation (KRW)	During pediatric procedural sedation (up to 1 day)
Onset time of rescue sedation (PSSS =1,2,3) (min)	Onset time of rescue sedation (Pediatric Sedation State Scale= 1,2,3) after rescue sedative administration.	During pediatric procedural sedation (up to 3 hour)
Duration of rescue sedation = Recovery time (PSSS =4,5)	Pediatric Sedation State Scale= 4,5 after recovery of sedation	During pediatric procedural sedation (up to 3 hour)
HR during sedation (/min)	HR(/min) at Baseline(T0), q 10min	During pediatric procedural sedation (up to 3 hour)
The incidence of respiratory intervention: Manual ventilation or Artificial airway %	The incidence of respiratory intervention: Manual ventilation or Artificial airway %	During pediatric procedural sedation (up to 3 hour)
The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)	The incidence of Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)	During pediatric procedural sedation (up to 3 hour)
The incidence of Rescue sedation failure (PSSS =0,4,5) after 30 min %	The incidence of Rescue sedation failure (PSSS =0,4,5) after 30 min %	During pediatric procedural sedation (up to 3 hour)
The incidence of Completion of procedure	The incidence of Completion of procedure	During pediatric procedural sedation (up to 3 hour)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: pediatric; procedural sedation; chloral hydrate; intranasal dexmedetomidine; intranasal ketamine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine; Chloral Hydrate
• Other Study ID Numbers: IN DEXKET rescue

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No