Comparison Between Oral and Enema of Chloral Hydrate

NCT03242629 | Completed DMC

• 1 other identifier: CCPMOH2017-China-6
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Congenital Cataract

Keywords

pediatric ophthalmic examination; chloral hydrate; Effects Comparison

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Side effect

  the following 48 hour after using the drug

• 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

Study Arms (2)

oral group

ACTIVE COMPARATOR

Drug: oral chloral hydrate

enema group

EXPERIMENTAL

Drug: enema chloral hydrate

Interventions

oral chloral hydrate DRUG

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.

oral group

enema chloral hydrate DRUG

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.

enema group

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

Chloral Hydrate

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Haotian Lin, M.D,Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 8, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08