Comparison between oral and nasal administration of preanesthetic medication

JRCT ID: jRCTs041180083

Registered date:12/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cleft lip and palate
• Date of first enrollment: 10/10/2018
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Oral or Nasal administration of Midazolam as preanesthetic medication

Outcome(s)

Primary Outcome

Patient's state at the time of administration
Ease of administration score

Secondary Outcome

Sedation score
Parentalseparation score
Mask Acceptance score

Key inclusion & exclusion criteria

• Age minimum: 1 year
• Age maximum: 10 year
• Gender: Both

Include criteria

1. Patients who undergo the surgery related cleft lip and palate
2. Age: 1 to 10 years old
3. We have confirmed the following major organ functions are within the normal
range one week before the surgery.
Hematological examination: white blood cells, platelets, hemoglobin
Blood biochemical test: AST, ALT, total bilirubin, ALP, LDH, creatinine, CK
4. Prior to the registration of this study, a sufficient explanation of this study was
given to the patient's substitute person and written consent by the patient's
substitute person was obtained.If possible, we will explain the contents of this
study to the patient himself using the informed ascent document and will
acquire the informed ascent by the patient himself.

Exclude criteria

1. Patients with severe heart disease, liver dysfunction, renal dysfunction
2. Patients with allergy or severe hypersensitivity to the study drug
3. Patient who was judged inappropriate by physician

Related Information

• Primary Sponsor: Okuda Masahiro
• Secondary ID(s): UMIN000032540