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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01149226
First received: June 16, 2010
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention
Pediatric
 Drug: chloral hydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Preoperative Anxiety [ Designated as safety issue: No ]

    Preoperative Anxiety Score

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


  • Induction Compliance [ Designated as safety issue: No ]

    Induction Compliance Checklist

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


  • Postoperative Pain [ Designated as safety issue: No ]

    -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


  • Posthospitalization Behavior [ Designated as safety issue: No ]

    Posthospitalization Behavior Questionnaire

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



Enrollment: 100
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo control Drug: chloral hydrate
30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.
Experimental: oral medication chloral hydrate Drug: chloral hydrate
30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. congenital hear disease
  2. renal disease
  3. liver disease
  4. growth retardation
  5. coagulopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149226

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Hae Keum Kil / Professor, Severance Hospital, YUHS
ClinicalTrials.gov Identifier: NCT01149226     History of Changes
Other Study ID Numbers: 4-2010-0084
Study First Received: June 16, 2010
Last Updated: June 9, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
pediatric patients
ASA physical status I or II
aged between 1-5 yrs

Additional relevant MeSH terms:
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 17, 2012