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Clinical observation of drug metabolism of chloral hydrate with different routes of administration in outpatient sedated infants and young children

Clinical observation of drug metabolism of chloral hydrate with different routes of administration in outpatient sedated infants and young children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081441
Enrollment
Unknown
Registered
2024-03-01
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural sedation

Interventions

Chloral hydrate enema group:Chloral hydrate with different routes of administration
Chloral hydrate oral group:Chloral hydrate with different routes of administration

Sponsors

Department of Anesthesiology, Hunan Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children undergoing procedural sedation within 0-3 months (guardians must sign the guardian version of the informed consent form)

Exclusion criteria

Exclusion criteria: (1) Allergy to the components of chloral hydrate enema. (2) Current concomitant with any of the following diseases: ? Diarrhea or anorectal disease that may affect drug absorption in the opinion of the investigator ? Intracranial hypertension ? Central apnea ? Respiratory neuromuscular disease ? Acute respiratory failure ? Obstructive sleep apnea syndrome ? Proctitis or colitis • Brain herniation ? Severe hepatic/renal insufficiency (ALT or AST> 5 times the upper limit of normal, or bilirubin > 2.5 times the upper limit of normal; SCr >176 µmol/L)? Severe cardiovascular disease (e.g., fulminant myocarditis, high- or third-degree atrioventricular block, sick sinus syndrome, hemodynamically unstable arrhythmia, cardiomyopathy, high pulmonary hypertension, pulmonary atresia, heart failure) ? Porphyria • Mitochondrial disease • Convulsions due to hypoglycemia, electrolyte imbalances, toxicity, liver failure, or hypertensive encephalopathy (3) Life expectancy of < 14 days due to imminent termination of life support or severity of illness. (4) There are other factors that the investigator considers unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
The original reflex returns to a 2-point horizontal time.;

Countries

China

Contacts

Public ContactWu Wei

Hunan Children's Hospital

www.9789639@qq.com+86 137 8731 3011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026