Comparison Between Oral and Enema of Chloral Hydrate

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03242629

Collaborator

(none)

120

Enrollment

Arms

5.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Drug: oral chloral hydrate Drug: enema chloral hydrate	N/A

Detailed Description

To compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.The patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to complete the examinations including slit-lamp photography, tonometry, anterior segment analysis, and refractive error inspection. The secondary endpoints included onset time, duration of examination, recovery time, discharge time, any side effects during examination, and within 48 h after discharge.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Effects Comparison Between Oral and Enema of Chloral Hydrate in Pediatric Ophthalmic Examination

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oral group	Drug: oral chloral hydrate Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.
Experimental: enema group	Drug: enema chloral hydrate Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.

Arm

Intervention/Treatment

Active Comparator: oral group

Drug: oral chloral hydrate

Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.

Experimental: enema group

Drug: enema chloral hydrate

Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.

Outcome Measures

Primary Outcome Measures

Demography (age, sex, weight， laterality and medical history) [baseline]
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire

Secondary Outcome Measures

Side effect [the following 48 hour after using the drug]
record the following symptom: Vomit after administration、Cough、SpO2 < 95%、SpO2 < 90%、New vomiting、Resume normal activity over 8 hour、Poor appetite、Altered bowel habit
the time of Sleepiness:Onset time (min） [baseline]
the time of Sleepiness:Duration of examination (min) [baseline]
the time of Sleepiness:Recovery time (min) [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosed with congenital cataract aged from 3 to 36 months weight from 5 to 15 kg with American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

with gastro-esophageal reflux, nausea and vomiting, apnea in the past 3 months recent pneumonia exacerbation of asthma, bronchitis and upper respiratory tract infection bradycardia, and facial abnormalities, allergy to chloral hydrate, weight <2 or >20 kg .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Haotian Lin, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haotian Lin, Clinical Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03242629

Other Study ID Numbers:

CCPMOH2017-China-6

First Posted:

Aug 8, 2017

Last Update Posted:

Aug 8, 2017

Last Verified:

Aug 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University

pediatric ophthalmic examination

chloral hydrate

Effects Comparison

Additional relevant MeSH terms:

Cataract

Chloral Hydrate

Study Results

No Results Posted as of Aug 8, 2017