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Comparison of the sedation effect of oral Ketamine and intranasal Midazolam in children undergoing upper endoscopy

Comparison of the sedation effect of oral Ketamine and intranasal Midazolam in children undergoing upper endoscopy at Rasht 17 Shahrivar hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014111419936N1
Enrollment
100
Registered
2014-12-12
Start date
2014-12-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation in endoscopy. During endoscopic examination

Interventions

Intervention 1: In the group Ketamin, 30 minutes prior to the endoscopy, 5 mg/kg of ketamine dissolved in 0.5 cc/kg of usp syrup (mixture of sucrose and water in a ratio of 85%) will be given to all c
Treatment - Drugs
In the group Ketamin, 30 minutes prior to the endoscopy, 5 mg/kg of ketamine dissolved in 0.5 cc/kg of usp syrup (mixture of sucrose and water in a ratio of 85%) will be given to all children and norm
In the midazolam group, 0.1 mg/kg administrate intranasal and the placebo usp syrup is fed.

Sponsors

The deputy of research of Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children who need endoscopy according to the pediatric gastroenterologist diagnosis. Patients should have not underlying problem and their age should be between of 2 and 14 years old. Exclusion criteria: patients with respiratory, heart, kidney and liver diseases and the apparent neurological inability or hypersensitivity to benzodiazepines and ketamine; no parental consent to sedate their patients; if an endoscopy complication occurs, such as bleeding and gastrointestinal endoscopy take too long.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: During and 1 hour after endoscopy. Method of measurement: Questionnaire and ramasy scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shohre Maleknejad

Guilan University of Medical Sciences

maleknejad@gums.ac.ir+98 13 3332 6101

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026