What is the recommended pediatric dose of Pedicloryl (triclofos sodium) for procedural or short‑term sedation in children?

Pediatric Dosing of Pedicloryl (Triclofos Sodium)

The recommended dose of Pedicloryl (triclofos sodium) for procedural sedation in children is 80 mg/kg orally, with the option to administer an additional 5 mg/kg every 5 minutes up to 60 minutes after the initial dose if adequate sedation is not achieved. 1

Standard Dosing Protocol

• Initial dose: 80 mg/kg orally is the established starting dose for children undergoing non-painful diagnostic procedures 1
• Supplemental dosing: 5 mg/kg every 5 minutes can be given starting at 30 minutes post-administration if the child remains inadequately sedated, continuing up to 60 minutes after the initial dose 1
• Typical effective dose range: 25–75 mg/kg, though most studies demonstrate efficacy at the higher end of this range 2
• Mean dose used in clinical practice: 50.2 ± 4.9 mg/kg across large pediatric populations 3

Onset and Duration

• Median time to sedation: 25–45 minutes after oral administration 1, 3
• Median duration of sedation: 35 minutes (range 5–190 minutes) 3
• Adequate sedation depth is achieved in approximately 88.5% of cases at standard dosing 3

Age and Weight Considerations

• Approved for children under 5 years of age, with most study populations having a mean age of 23–25 months 1, 3
• Mean weight in studied populations: 12 kg (SD 3.84) 1
• The medication has been safely used in children ranging from 5 to 200 months of age 3

Clinical Context and Indications

• Triclofos sodium is indicated for non-painful diagnostic procedures including electroencephalography, audiometry, and ophthalmic examinations 1, 3
• It is particularly useful in children with neurocognitive disorders, including those with seizures, hypotonia, or developmental delay, where it has demonstrated a favorable safety profile 3
• The medication is physiologically and pharmacologically similar to chloral hydrate but is available as a sweet syrup formulation that improves palatability 3, 2

Safety Profile and Monitoring

• Desaturation (≤90%) occurs in only 0.2% of cases, with no reported apnea events in large observational studies 3
• Emesis occurs in 0.35% of sedated children 3
• No hemodynamic instability or signs of poor perfusion have been reported at recommended doses 3
• Continuous monitoring of heart rate and arterial oxygen saturation is required throughout the sedation period 1

Important Caveats

• Sedation failure rate: 11.5% at standard dosing, requiring alternative sedation methods such as general anesthesia 3
• The procedure should be considered a failure if the Ramsay sedation score remains ≤4 after 60 minutes of initial drug administration 1
• Triclofos must be administered in a controlled and monitored environment with appropriate resuscitation equipment available 3
• There is no association between desaturations and underlying neurocognitive conditions such as hypotonia or developmental delay, making it relatively safe in this population 3

Comparison to Alternative Agents

• When compared to oral midazolam (0.5 mg/kg), triclofos at 75 mg/kg demonstrates similar sedation scores, anxiety levels, and behavioral outcomes during parental separation and procedure initiation 2
• Unlike midazolam, triclofos has a more predictable response and is available as a palatable sweet syrup 2