Comparison Between Oral and Enema of Chloral Hydrate

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242629
• Other study ID #: CCPMOH2017-China-6
• Status: Completed
• Phase: N/A
• First received: July 30, 2017
• Last updated: August 3, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 36 Months

Eligibility

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 .

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demography (age, sex, weight, laterality and medical history)	The demography of cataract and healthy children were recorded by using a semi-structured questionnaire	baseline
Secondary	Side effect	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 following 48 hour after using the drug
Secondary	the time of Sleepiness:Onset time (min)		baseline
Secondary	the time of Sleepiness:Duration of examination (min)		baseline
Secondary	the time of Sleepiness:Recovery time (min)		baseline