Triclofos (Pedicloryl)

Triclofos (Pedicloryl) is a chloral hydrate derivative commonly employed as a sedative-hypnotic, especially within paediatric settings. It functions by depressing central nervous system (CNS) activity, promoting sedation that facilitates diagnostic evaluations in young patients. Administered orally, typically as a palatable syrup, Triclofos (Pedicloryl) provides an effective, non-invasive alternative to general anaesthesia for procedures such as EEGs and neuroimaging. This drug remains an essential component in paediatric procedural sedation due to its favourable safety profile and ease of administration.

Image source Google

Clinical Applications

The primary indication for Triclofos (Pedicloryl) is short-term sedation in paediatric patients undergoing non-painful diagnostic procedures that require immobility, such as MRI, CT scanning, and EEGs. It is occasionally utilised in managing acute episodes of sleep disturbances in children and selected adults. Its use in dental interventions and minor surgical procedures has also been documented when general anaesthesia is deemed unnecessary. While not suitable for chronic insomnia, Triclofos (Pedicloryl)'s predictable sedative effects and acceptable safety margin make it a mainstay in transient sedation strategies.

Dosage and Administration Protocols

The dosing of Triclofos (Pedicloryl) should be individualised, factoring in patient age, weight, and comorbidities. The recommended paediatric dosage is 20–75 mg/kg, typically given 30–60 minutes prior to the procedure. Administered orally, the drug usually induces sedation within 30 minutes, with effects persisting for approximately 6–8 hours. It is imperative to administer Triclofos (Pedicloryl) under medical supervision to promptly identify and manage adverse reactions. Re-dosing may be considered under strict clinical guidance if the initial effect proves inadequate.

Dose Adjustments in Special Populations

Renal Dysfunction: Although primarily metabolised hepatically, Triclofos (Pedicloryl)’s metabolites are eliminated renally. In individuals with compromised renal function, accumulation of these metabolites may extend sedation or potentiate toxicity. Dose reduction and vigilant monitoring are essential.
Hepatic Impairment: The conversion of Triclofos (Pedicloryl) to its active metabolite, trichloroethanol, occurs in the liver. Hepatic impairment may slow this process, warranting initiation at the lower end of the dosing spectrum with close titration.
Pregnancy and Lactation: Categorised as Pregnancy Category C, Triclofos (Pedicloryl) should be avoided unless benefits outweigh potential foetal risks. There is insufficient human data, and animal models suggest possible teratogenicity. As the drug can pass into breast milk, it is contraindicated in breastfeeding women.

Pharmacological Effects and Adverse Reactions

Triclofos (Pedicloryl) exerts CNS depressant effects that induce natural sleep-like sedation. Mild side effects include nausea, dizziness, headache, and drowsiness. Some paediatric patients may exhibit paradoxical agitation or irritability. Severe adverse reactions, though rare, include bradycardia, hypotension, and respiratory depression, necessitating close monitoring of vital parameters, particularly in vulnerable or polymorbid patients.

Combination Therapies and Infusion Considerations

In scenarios demanding deeper sedation, Triclofos (Pedicloryl) may be used synergistically with benzodiazepines or antihistamines. These combinations must be approached cautiously, as additive CNS depressant effects can increase risk profiles. When other agents are being infused, compatibility and administration timing must be rigorously checked. Direct IV use or mixing with alcohol or incompatible substances is strictly contraindicated.

Pharmaceutical Presentation

Triclofos (Pedicloryl) is predominantly available as an oral syrup, which enhances compliance among paediatric patients. The syrup formulation supports accurate weight-based dosing and palatability.

Formulation	Strength	Dose Range (mg/kg)	Onset of Action	Duration of Action
Syrup	500 mg/5 ml	20–75 mg/kg	~30 minutes	6–8 hours

You should also know about: Linezolid

Pharmacokinetics and Pharmacodynamics

Triclofos (Pedicloryl) is rapidly absorbed via the gastrointestinal tract and converted hepatically into trichloroethanol, its active metabolite. Peak plasma concentrations are achieved within 1–2 hours. The drug exhibits sedative-hypnotic effects through CNS depression. Elimination occurs mainly through the kidneys. Importantly, Triclofos (Pedicloryl) possesses no antimicrobial or antibacterial activity and is not indicated for infections.

Interactions with Concomitant Medications

Triclofos (Pedicloryl) exhibits clinically significant interactions with CNS depressants such as opioids, barbiturates, antipsychotics, and antiepileptics. CYP450-modifying agents like phenytoin or erythromycin may alter its metabolism. Careful assessment of concomitant medications is essential to avoid enhanced sedation or toxicity.

Comparative Analysis with Similar Agents

Agent	Onset Time	Duration	Administration Route	Sedation Level	Paediatric Use	Comments
Triclofos (Pedicloryl)	~30 mins	6–8 hours	Oral	Mild–Moderate	Yes	Well-tolerated and palatable syrup form
Midazolam	~15 mins	1–2 hours	IV/Oral	Moderate–Deep	Yes	Suitable for short procedures
Chloral Hydrate	~30 mins	4–8 hours	Oral	Mild	Yes	Less palatable; older agent
Dexmedetomidine	~10 mins	1–2 hours	IV	Deep	Limited	Higher cost; requires close haemodynamic monitoring
Melatonin	~20 mins	3–4 hours	Oral	Mild	Yes	Non-sedative therapy; behavioural adjunct

Precautions and Clinical Considerations

Caution is warranted when using Triclofos (Pedicloryl) in children with respiratory compromise, such as asthma or obstructive sleep apnoea. Baseline renal and hepatic function should be evaluated before administration, particularly for recurrent dosing. Continuous sedation or repeated use without reevaluation is discouraged due to dependency risks.

Overdose Management and Toxicity

Toxic ingestion of Triclofos (Pedicloryl) may result in CNS suppression, respiratory failure, hypotension, and coma. No specific antidote exists. Management includes airway support, oxygen supplementation, cardiovascular stabilisation, and decontamination measures like gastric lavage or activated charcoal if administered early.

2025 Clinical Updates and Guidelines

The latest 2025 guidelines by the European Society of Paediatric Anaesthesiology recommend that Triclofos (Pedicloryl) be restricted to use within controlled medical settings. Home-based administration is discouraged due to safety concerns. Emphasis has also been placed on incorporating non-pharmacological interventions such as behavioural therapy alongside lower sedative doses to minimise medication dependence.