PediatricNCT01149226
Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery
A study testing chloral hydrate in people with Pediatric, run by Yonsei University at 1 site in South Korea.
Trial summary
Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Pediatric
- What is being tested?
- chloral hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I or II
- 1-5 years children
- elective day-case orchiopexy
Who cannot join
- congenital hear disease
- renal disease
- liver disease
- growth retardation
- coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery
- Conditions
- Pediatric
- Being tested
- chloral hydrate
- Keywords
- pediatric patients, ASA physical status I or II, aged between 1-5 yrs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloral hydrateDrug
30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.
| Study group | Role | What they receive |
|---|---|---|
| placebo control | Placebo comparator | Not described Receives: Drug: chloral hydrate |
| oral medication chloral hydrate | Experimental | Not described Receives: Drug: chloral hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149226
- Sponsor's protocol ID
- 4-2010-0084
- Status last verified
- Jun 2011
- First submitted
- 16 Jun 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery
- ClinicalTrials.gov ID
- NCT01149226
- Acronym / sponsor ID
- 4-2010-0084
- Conditions
- Pediatric
- Keywords
- pediatric patients, ASA physical status I or II, aged between 1-5 yrs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo control | Placebo comparator | Drug: chloral hydrate |
| oral medication chloral hydrate | Experimental | Drug: chloral hydrate |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I or II
- 1-5 years children
- elective day-case orchiopexy
Key exclusion criteria (5 listed)
- congenital hear disease
- renal disease
- liver disease
- growth retardation
- coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloral hydrate30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally. | Drug | oral medication chloral hydrate, placebo control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chloral hydrate in people with Pediatric, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.