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Comparison of the effect of intravenous ketamine and midazolam as a premedication in children .

Comparison of the effect of intravenous ketamine and midazolam as a premedication in children undergoing cochlear implantation at the time of separation from parents

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161022030421N3
Enrollment
74
Registered
2019-06-15
Start date
2640-01-21
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Seduction of the chorus and dumb children.

Interventions

Intervention 1: Intervention group (Midazolam): In this group, midazolam will be given with dose of one tenth of mg / kg of midazolamole in a 5-cc syringe and diluted into 5 cc distilled water. In pre

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 5 Years

Inclusion criteria

Inclusion criteria: Children from 6 months to 5 years of age with ASA class I and II, candidate for cochlear implant

Exclusion criteria

Exclusion criteria: Children with known sensitivity to ketamine or midazolam, as well as history of taking psychiatric medications, age less than 6 months, increased ICP, brain tumor masses, history of seizure, upper and lower respiratory tract infection.

Design outcomes

Primary

MeasureTime frame
Sedation when separating from parents. Timepoint: In the pre-operative room, when the child is separated from the parents. Method of measurement: Observe and filling the form of sedation anxiety score scale (SASS).;Sedation of the child during induction of anesthesia. Timepoint: On the operating room bed, Induction of anesthesia. Method of measurement: Using the form of sedation anxiety score scale (SASS).;Child sedation in recovery. Timepoint: From the child's arrival to the recovery until the release of the recovery. Method of measurement: Using PACU sedation score scale (PACUSSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Lak

Bagheiat-allah University of Medical Sciences

marziehlak@bmsu.ac.ir+98 212449013

Outcome results

None listed

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