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