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Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department

Effectiveness of oral ketamin,Midazolam and Atropine cocktail versus oral Diphenhydramin for pediatric Sedation in Emergency Department

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201212312496N8
Enrollment
80
Registered
2013-01-03
Start date
2013-01-20
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 during procedure. sedation(conscious) (moderate) during procedure

Interventions

Intervention 1: Oral Diphenhydramin : 0.5mg/kg. Intervention 2: Oral ketamin(6mg/kg), Midazolam(0.05mg/kg) and Atropine(0.02mg/kg) cocktail.
Prevention
Oral Diphenhydramin : 0.5mg/kg
Oral ketamin(6mg/kg), Midazolam(0.05mg/kg) and Atropine(0.02mg/kg) cocktail

Sponsors

Research Vice chancellor of Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children aged 2-10 years having referred to the emergency department for wound stitches requiring local anesthesia prior to the procedure. Exclusion criteria: Patients with the history of psychologic or mental disorders, children with attention deficit-hyperactivity disorder, multiple traumas, GCS<15, common cold, unwillingness of the parents to take part in the study, illiterate parents, known allergy, prior history of erythromycin administration, chronic underlying diseases such as convulsive disorders, patients with lower-extremity ulcers, mucosal ulcers, wounds larger than 4 centimeters or with the depth of more than 0.5 centimeters and single ulcers, too.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: Every 5 minutes to 45 minutes after administration of sedatives. Method of measurement: Grade 1: drowsiness, the patient needs a stimulus for waking up- Grade 2: drowsiness, the eyes are closed and patient needs a mild verbal or touch stimulus for waking up- Grade 3: drowsiness, the eyes are open but the eye responsiveness has reduced to low activity- Grade 4: complete awakeness- Grade 5: complete agitation.

Secondary

MeasureTime frame
All behavioral patterns of the child including cry, consciousness, and movement throughout the procedure. Timepoint: When local anesthetic injecting and during the procedure. Method of measurement: Based on the Houpt scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Hassan Soleimanpour

Tabriz University of Medical Sciences

h_mofid1357@yahoo.com+98 41 1335 2078

Outcome results

None listed

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