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CompletedNCT01149226Updated Jun 10, 2011

Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery

An interventional study of chloral hydrate in Pediatric, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2011-06-10.

Sponsored by Yonsei University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
01

Study summary

Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery

02

Conditions studied

  • Pediatric

Keywords

  • pediatric patients
  • ASA physical status I or II
  • aged between 1-5 yrs
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ASA I or II
  2. 1-5 years children
  3. elective day-case orchiopexy

Exclusion criteria

Exclusion Criteria:

  1. congenital hear disease
  2. renal disease
  3. liver disease
  4. growth retardation
  5. coagulopathy
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    placebo control

    Drug: chloral hydrate

  • Experimental
    oral medication chloral hydrate

    Drug: chloral hydrate

Interventions

  • Drugchloral hydrate

    30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.

06

What researchers measure

Primary outcomes

  1. Preoperative Anxiety

    Preoperative Anxiety Score Modified Yale Preoperative Anxiety Scale (YPAS, 0-100) was assessed by observer Anesth Analg 1997;85:783-8

  2. Induction Compliance

    Induction Compliance Checklist Induction Compliance Checklists (ICC, 0-10) was assessed by anesthetist Anesthesiology 1998;89:1147-56

  3. Postoperative Pain

    -Postoperative Pain Score Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale (0-10) was assessed by observer Am J Crit Care. 2010 Jan;19(1):55-61

  4. Posthospitalization Behavior

    Posthospitalization Behavior Questionnaire Posthospitalization Behavioural Questionnaire (27-135)was sent to all parents of children Paediatr Anaesth. 2001 Nov;11(6):719-23.

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01149226
Lead sponsor
Yonsei University
First posted
Jun 28, 2010
Start date
May 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jun 10, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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