NCT01149226

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

June 16, 2010

Last Update Submit

June 9, 2011

Conditions

Pediatric

Keywords

pediatric patientsASA physical status I or IIaged between 1-5 yrs

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (2)

placebo control

PLACEBO COMPARATOR
Drug: chloral hydrate

oral medication chloral hydrate

EXPERIMENTAL
Drug: chloral hydrate

Interventions

chloral hydrateDRUG

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

oral medication chloral hydrateplacebo control

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I or II
  • years children
  • elective day-case orchiopexy

You may not qualify if:

  • congenital hear disease
  • renal disease
  • liver disease
  • growth retardation
  • coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Chloral Hydrate

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 28, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

KR(1)