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

Tracking Information
First Received Date ^ICMJE	June 16, 2010
Last Updated Date	June 9, 2011
Start Date ^ICMJE	May 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01149226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery
Official Title ^ICMJE	Not Provided
Brief Summary	Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver)
Condition ^ICMJE	Pediatric
Intervention ^ICMJE	Drug: chloral hydrate 30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.
Study Arm (s)	Placebo Comparator: placebo control Intervention: Drug: chloral hydrate Experimental: oral medication chloral hydrate Intervention: Drug: chloral hydrate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ASA I or II 1-5 years children elective day-case orchiopexy Exclusion Criteria: congenital hear disease renal disease liver disease growth retardation coagulopathy
Gender	Both
Ages	1 Year to 5 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01149226
Other Study ID Numbers ^ICMJE	4-2010-0084
Has Data Monitoring Committee	No
Responsible Party	Hae Keum Kil / Professor, Severance Hospital, YUHS
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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