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

Not Applicable

Completed

• Conditions: Pediatric
• Interventions: Drug: chloral hydrate

• Registration Number: NCT01149226
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-28
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral medication chloral hydrate	chloral hydrate	-
placebo control	chloral hydrate	-

Primary Outcome Measures

Name	Time	Method
Preoperative Anxiety		Preoperative Anxiety Score; Modified Yale Preoperative Anxiety Scale (YPAS, 0-100) was assessed by observer Anesth Analg 1997;85:783-8
Induction Compliance		Induction Compliance Checklist; Induction Compliance Checklists (ICC, 0-10) was assessed by anesthetist Anesthesiology 1998;89:1147-56
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
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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of