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comparison of sedative effect of Dexmedetomidine,Midazolam and Ketamine in outpatient pediatric surgeries

comparison of sedative effect of intranasal Dexmedetomidine,Midazolam and Ketamine in outpatient pediatric surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013081614372N1
Enrollment
90
Registered
2014-02-11
Start date
2013-07-23
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

Restlessness and agitation. Symptoms and signs involving emotional state

Interventions

Intervention 1: intra nasal midazolam 0.2 mg/kg ,45-60 minutes before induction. Intervention 2: Intranasal ketamine 8mg/kg ,45-60 minutes before induction. Intervention 3: Intranasal dexmedetomidine
Treatment - Drugs
intra nasal midazolam 0.2 mg/kg ,45-60 minutes before induction
Intranasal ketamine 8mg/kg ,45-60 minutes before induction
Intranasal dexmedetomidine 1.5 mic /kg ,45-60 minutes before induction

Sponsors

Shiraz University of Medical Sciences. Research chancellor
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: children aged between 2-7 year; ASA classification I-II; unilateral inguinal herniorraphy Exclusion criteria: Hx. of hypersensitivity to drugs of the study(Midazolam; Ketamine and Dexmedetomidine); liver failure; renal failure; upper respiratory tract infection; cardiac arrythmia; congenital heart disease; neurologic disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Anxiety. Timepoint: Every 10 min after seperation of parents. Method of measurement: Observation( Four point scale).;Pain. Timepoint: Every 15min in PACU. Method of measurement: Observation( Modified objective pain scale).;Nausea &vomiting. Timepoint: Recovery time. Method of measurement: observation.;Sedation. Timepoint: Every 10 minutes. Method of measurement: Obsevation( Modified observer's assessment alertness sedation).

Secondary

MeasureTime frame
Sedation scale in PACU. Timepoint: Every 15 min. Method of measurement: Observation( Modified observer's assessment alertness sedation).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Keihani

Shiraz University of Medical Sciences

keihani@sums.ac.ir+98 71 1231 8072

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026