Establishment of evidences for usage of sedative drugs in neonates and children: Evaluation of the dosage, efficacy, and safety of midazolam.

UMIN ID: UMIN000000526

Registered date:22/11/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Mechanically ventilated neonates and children.
• Date of first enrollment: 2006/11/01
• Target sample size: 75
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Midazolam

Outcome(s)

• Primary Outcome: Success rate for sedation with midazolam in evaluating sedative state by Ramsay sedation score
• Secondary Outcome: Adverse event/Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 15years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Health and Labour Science Research Grants for Clinical Research on Pediatric disease(Evaluation of the dosage, efficacy, and safety of midazolam)study groups.
• Source(s) of Monetary Support: Health and Labour Science Research Grants for Clinical Research on Pediatric disease