Mechanically ventilated neonates and children.
Conditions
Interventions
Midazolam
Sponsors
Health and Labour Science Research Grants for Clinical Research on Pediatric disease(Evaluation of the dosage, efficacy, and safety of midazolam)study groups.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Mechanically ventilated neonates and children are included: 1) whose post-conceptional age are between 23 weeks and 15 years old, 2) who are obtained informed consent.
Exclusion criteria
Exclusion criteria: Neonates and children are excluded: 1) who are given paralyzing and sedative drugs continuously. 2) who are given the drugs listed on the drugs do not use. 3) who have severe congenital malformation and chromosomal anomaly. 4) who have neurological disease (ex. severe neonatal asphyxia, severe central nerve impairment, and congenital metabolic diseases) by which it is difficult to evaluate the sedative state. 5) who have severe liver dysfunction, or renal dysfunction. 6) who have hyper reactivity to midazolam and other drugs. 7) who have acute glaucoma. 8) who have severe myasthenia gravis. 9) who are given HIV protease inhibitor, or HIV reverse transcriptase inhibitor. 10) who have alcoholism with shock, come, and depressed vital sign. 11) who have already attended to this study. 12) who are diagnosed not suitable for this study by attending doctors because of their psychological or social factors. 13) who are diagnosed not suitable for this study by attending doctors 14) whose parents change their mind and want not to attend to this study afterward. 15) who are given midazolam by bolus intravenous injection only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate for sedation with midazolam in evaluating sedative state by Ramsay sedation score | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event/Pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactYushi Itoh ,MD
National Center for Child Health and Development Division of Neonatology, Department of Perinatology and Maternal Care.
Outcome results
None listed