Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging

The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.

Study Overview

• Status: Completed
• Conditions: Failed Moderate Sedation During Procedure; Administration Related Reaction; Chloral Hydrate Adverse Reaction
• Intervention / Treatment: Drug: chloral hydrate Group; Drug: low dose dexmedetomidine group; Drug: high dose dexmedetomidine group

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Department of Anesthesiology of Guangzhou Women and Children's Medical Center
    • Guangzhou, Guangdong, China
      • Guangzhou Women and Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning

Exclusion Criteria:

• known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: chloral hydrate group; chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)	Drug: chloral hydrate Group; chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
Experimental: low dose dexmedetomidine Group; Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.	Drug: low dose dexmedetomidine group; Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup; Other Names: AiBeiNing
Experimental: high dose dexmedetomidine group; Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup Undiluted preservative-free dexmedetomidine (AiBeiNing; Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) was prepared in a concentration of 100mcg/ml and dripped into both nostrils using a 1 mL syringe with the child in the Supine position.	Drug: high dose dexmedetomidine group; Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup; Other Names: AiBeiNing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful rescue sedation rate	Sedation status was evaluated by a attending anesthesiologists every 5-10 min with a 6-point sedation scale, which was modified from the Observer Assessment of Alertness and Sedation Scale (MOAA/S; Table 1). successful sedation was defined as an MOAA/S of between 0 and 3	up to 1 hours after MRI scaning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wake -up time	Children were classified as awake if the MOAA/S was between 4 and 6. Wake -up time was defined as the time from successful sedation until the time that the child awoke	up to 4 hours after rescue drug administration
sedation induction time	Successful sedation was defined as an MOAA/S of between 0 and 2, and sedation induction time was defined as the time from rescue drug administration to the onset of satisfactory sedation 0 Does not respond to a noxious stimulus; Does not respond to mild prodding or shaking; Responds only after mild prodding or shaking; Responds only after name is called loudly orrepeatedly; Lethargic response to name spoken in normal tone; Appears asleep, but responds readily to namespoken in normal tone; Appears alert and awake, responds readily to namespoken in normal tone	up to 30 min after rescue drug administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxyhemoglobin desaturation	Significant Oxyhemoglobin desaturation was defined as<94%	baseline and four hours after rescue medicine administration
non-invasive systolic blood pressure	changes in the non-invasive systolic blood pressure at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration	baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
heart rate	changes in heart rates at the baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration	baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center

Publications and helpful links

General Publications

• Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
• 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.
• Miller J, Xue B, Hossain M, Zhang MZ, Loepke A, Kurth D. Comparison of dexmedetomidine and chloral hydrate sedation for transthoracic echocardiography in infants and toddlers: a randomized clinical trial. Paediatr Anaesth. 2016 Mar;26(3):266-72. doi: 10.1111/pan.12819. Epub 2015 Nov 30.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 9, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• 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; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine; Chloral Hydrate
• Other Study ID Numbers: WZhang