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

Sedation Clinical Trial

Official title:

Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820205
• Other study ID #: IN DEXKET first
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, MD, PhD
• Phone: 82-2-2072-3664
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

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)
• Oral chloral hydrate
Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of adequate sedation (PSSS= 1,2,3) within 15 minutes %	Success rate of adequate sedation (Pediatric Sedation State Scale= 1,2,3) within 15 minutes after sedative administration. %	During pediatric procedural sedation (up to 1 hour)
Secondary	Onset time of sedation (PSSS= 0,1,2,3) (min)	Onset time of sedation (Pediatric Sedation State Scale= 1,2,3) after sedative administration.	During pediatric procedural sedation (up to 3 hour)
Secondary	Duration of sedation = Recovery time (PSSS= 4,5) (min)	Pediatric Sedation State Scale= 4,5 after recovery of sedation	During pediatric procedural sedation (up to 3 hour)
Secondary	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)
Secondary	Heart rate during sedation (/min)	HR(/min) at Baseline(T0), q 10min	During pediatric procedural sedation (up to 3 hour)
Secondary	SpO2 during sedation (%)	SpO2(%) by pulse oximetry at Baseline(T0), q 10min	During pediatric procedural sedation (up to 3 hour)
Secondary	Respiratory rate during sedation (/min)	RR(/min) at Baseline(T0), q 10min	During pediatric procedural sedation (up to 3 hour)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The incidence of significant apnea (>20seconds) %	The incidence of significant apnea (>20seconds) %	During pediatric procedural sedation (up to 3 hour)
Secondary	The lowest SpO2 value (%)	The lowest SpO2 value (%)	During pediatric procedural sedation (up to 3 hour)
Secondary	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)
Secondary	The incidence of significant bradycardia (-30% from baseline) %	The incidence of significant bradycardia (-30% from baseline) %	During pediatric procedural sedation (up to 3 hour)
Secondary	The incidence of significant hypotension (-30% from baseline) %	The incidence of significant hypotension (-30% from baseline) %	During pediatric procedural sedation (up to 3 hour)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The incidence of other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)	Other side effects (Ex: Nausea/Vomit, Allergic reaction, Etc)	During pediatric procedural sedation (up to 3 hour)
Secondary	The incidence of failure of adequate sedation (PSSS= 0, 4,5) after 30 min %	Failure of adequate sedation (PSSS= 0, 4,5) after 30 min %	During pediatric procedural sedation (up to 3 hour)
Secondary	The incidence of completion of procedure	Completion of procedure	During pediatric procedural sedation (up to 3 hour)
Secondary	Total cost of sedation (KRW)	Total cost of sedation (KRW)	During pediatric procedural sedation (up to 1 day)