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

NCT04822064 | Unknown

• 1 other identifier: IN DEXKET rescue
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Sedation

Keywords

pediatric; procedural sedation; chloral hydrate; intranasal dexmedetomidine; intranasal ketamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Onset time of rescue sedation (PSSS =1,2,3) (min)

  During pediatric procedural sedation (up to 3 hour)

• Duration of rescue sedation = Recovery time (PSSS =4,5)

  During pediatric procedural sedation (up to 3 hour)

• PSSS(Pediatric Sedation State Scale, 0-5)

  During pediatric procedural sedation (up to 3 hour)

• HR during sedation (/min)

  During pediatric procedural sedation (up to 3 hour)

• SpO2 during sedation (%)

  During pediatric procedural sedation (up to 3 hour)

Study Arms (2)

intranasal dexmedetomdine and kemtaine

EXPERIMENTAL

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

oral chloral hydrate

ACTIVE COMPARATOR

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

Interventions

Intranasal dexmedetomidine and ketamine DRUG

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)

intranasal dexmedetomdine and kemtaine

Oral chloral hydrate DRUG

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)

oral chloral hydrate

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

RECRUITING

Related Publications (8)

• 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.

  PMID: 26714442 BACKGROUND

• 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.

  PMID: 28414899 BACKGROUND

• 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.

  PMID: 24237879 BACKGROUND

• 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.

  PMID: 25822924 BACKGROUND

• 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.

  PMID: 27627818 BACKGROUND

• 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.

  PMID: 28639236 BACKGROUND

• 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.

  PMID: 30032884 BACKGROUND

• 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.

  PMID: 28319161 BACKGROUND

MeSH Terms

Interventions

Ketamine; Chloral Hydrate

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethylene Glycols; Glycols; Alcohols

Central Study Contacts

Jin-Tae Kim, MD. PhD

CONTACT

82-2-2072-3664; jintae73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 30, 2021
• Study Start: September 22, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)