Comparison Between Oral and Enema of Chloral Hydrate

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Congenital Cataract

Intervention / Treatment
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* Drug: oral chloral hydrate
* Drug: enema chloral hydrate


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral group<br> | Drug: oral chloral hydrate<br>* 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.<br>|
| Experimental: enema group<br> | Drug: enema chloral hydrate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric ophthalmic examination, chloral hydrate, Effects Comparison