Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children

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ClinicalTrials.gov Identifier: NCT04820205

Recruitment Status : Recruiting

First Posted : March 29, 2021

Last Update Posted : May 9, 2022

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Sponsor:

Information provided by (Responsible Party):

Jin-Tae Kim, Seoul National University Hospital

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Sedation	Drug: Intranasal dexmedetomidine and ketamine Drug: Oral chloral hydrate	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	136 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial
Actual Study Start Date :	September 3, 2021
Estimated Primary Completion Date :	December 31, 2025
Estimated Study Completion Date :	December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Chloral hydrate Ketamine Dexmedetomidine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: intranasal dexmedetomdine and kemtaine Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)	Drug: Intranasal dexmedetomidine and ketamine Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
Active Comparator: oral chloral hydrate Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)	Drug: Oral chloral hydrate Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Onset time of sedation (PSSS= 0,1,2,3) (min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration.
Duration of sedation = Recovery time (PSSS= 4,5) (min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Pediatric Sedation State Scale= 4,5 after recovery of sedation
PSSS(Pediatric Sedation State Scale, 0-5) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
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
Heart rate during sedation (/min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
HR(/min) at Baseline(T0), q 10min
SpO2 during sedation (%) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
SpO2(%) by pulse oximetry at Baseline(T0), q 10min
Respiratory rate during sedation (/min) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
RR(/min) at Baseline(T0), q 10min
the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
the incidence of PSSS=0 (Abnormal physiologic parameter that require acute intervention) %
The incidence of respiratory intervention: Manual ventilation or Artificial airway % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
The incidence of respiratory intervention: Manual ventilation or Artificial airway
The incidence of significant desaturation (SpO2 < 95% or -10% from baseline, >10 seconds) % [ Time Frame: 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 apnea (>20seconds) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
The incidence of significant apnea (>20seconds) %
The lowest SpO2 value (%) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
The lowest SpO2 value (%)
The incidence of hemodynamic intervention: fluid management, intravenous medication % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
The incidence of hemodynamic intervention: fluid management, intravenous medication %
The incidence of significant bradycardia (-30% from baseline) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
The incidence of significant bradycardia (-30% from baseline) %
The incidence of significant hypotension (-30% from baseline) % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
The incidence of significant hypotension (-30% from baseline) %
Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Patients' acceptance (1=excellent, 2=good, 3=fair, 4=poor)
Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Separation anxiety (1=easy, 2=whimper, 3=cry, 4=cry and cling to parents)
Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Physicians' satisfaction (1=excellent, 2=good, 3=fair, 4=poor)
The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc) [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)
The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min % [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Failure of adequate sedation (PSSS= 0, 4,5) after 30 min %
The incidence of completion of procedure [ Time Frame: During pediatric procedural sedation (up to 3 hour) ]
Completion of procedure
Total cost of sedation (KRW) [ Time Frame: During pediatric procedural sedation (up to 1 day) ]
Total cost of sedation (KRW)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 7 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820205

Contacts

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Contact: Jin-Tae Kim, MD, PhD	82-2-2072-3664	jintae73@gmail.com

Locations

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Korea, Republic of
Jin-Tae Kim	Recruiting
Seoul, Korea, Republic of
Contact: Jin-Tae Kim, MD. PhD 82-2-2072-3664 jintae73@gmail.com

Sponsors and Collaborators

Seoul National University Hospital

More Information

Publications:

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.

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, 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.

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.

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. Review.

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Responsible Party:	Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT04820205
Other Study ID Numbers:	IN DEXKET first
First Posted:	March 29, 2021 Key Record Dates
Last Update Posted:	May 9, 2022
Last Verified:	May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Jin-Tae Kim, Seoul National University Hospital:


pediatric procedural sedation chloral hydrate intranasal dexmedetomidine intranasal ketamine

Additional relevant MeSH terms:

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Dexmedetomidine Ketamine Chloral Hydrate Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists	Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents

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