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

Phase 1

Conditions: sedation during procedure.
sedation(conscious) (moderate) during procedure
T88.52

Registration Number: IRCT201212312496N8

Lead Sponsor: Research Vice chancellor of Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 80

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

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.