Emergence Agitation Clinical Trial
Official title:
Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study
The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 10 Years |
Eligibility | Inclusion Criteria: - Patients of American Society of Anesthesiologists (ASA) physical status I & II - both genders, - = 2 to 10 years, - scheduled for elective day case surgery under general anesthesia Exclusion Criteria: - parents' refusal for participation in the study - ASA III and VI patients with history of chronic illness - runny nose or upper respiratory tract infection - Emergency surgeries with hemodynamic instability - history of allergic reaction to dexmedetomidine or melatonin - History of prematurity - developmental delay - central nervous system disorder, - mental retardation, - neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.). - treatment with anticonvulsants and sedatives |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain shams university hospital | Cairo | Abbasia |
Lead Sponsor | Collaborator |
---|---|
nada moahmed aboelrouse |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | perioperative anxiety | perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following:
Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1) Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2) Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3) Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response |
during the patient separation from the caregiver just as the child is going to the operating theater | |
Secondary | mask acceptance | calculated according to the mask acceptance scale (MAS) as following : if the Child is calm, cooperative, or asleep the score will be (1) if the child is in Moderate fear of the mask Manageable with reassurance the score will be(2) if the child Cries, combative and needs restraining the score will be (3)
score of (1) means excellent response ,score of (2) means fair response and score of (3) means poor response |
during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision | |
Secondary | post anesthesia emergence agitation | will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED) with score
1= calm , 2= not calm but could be easily consoled , 3= moderately agitated or restless and not easily calmed , 4 = combative , excited , thrashing around |
first 15 minutes after admission to post- anesthesia care unit | |
Secondary | pain score | using Face, leg, activity, cry and Consolability score With score of 0 meaning no pain and requires no intervention and score of 10 indicating the worst imaginable pain requiring rescue analgesia | during hospital stay up to 3 hours |
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