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

Pediatric Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149226
• Other study ID #: 4-2010-0084
• Status: Completed
• Phase: N/A
• First received: June 16, 2010
• Last updated: June 9, 2011
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Pediatric

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative Anxiety	Preoperative Anxiety Score; Modified Yale Preoperative Anxiety Scale (YPAS, 0-100) was assessed by observer Anesth Analg 1997;85:783-8		No
Primary	Induction Compliance	Induction Compliance Checklist; Induction Compliance Checklists (ICC, 0-10) was assessed by anesthetist Anesthesiology 1998;89:1147-56		No
Primary	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		No
Primary	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.		No