Actively Recruiting
Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
Led by Tanta University · Updated on 2026-01-16
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of oral melatonin versus nebulized dexmedetomidine in reducing emergence agitation in children aged 3 to 7 years undergoing adenotonsillectomy, a common surgery with a high risk of agitation and pain after anesthesia. The study evaluates these treatments to find better ways to manage anxiety and pain during recovery in pediatric patients. It is a prospective, randomized controlled trial sponsored by Tanta University. Participants are randomly assigned to one of three groups: one receiving a placebo nebulizer with midazolam in apple juice, another receiving oral melatonin syrup with a placebo nebulizer, and the third receiving nebulized dexmedetomidine with placebo syrup. These treatments are given before surgery to study their effects on emergence agitation and related symptoms. The trial uses a double-blind design to ensure unbiased results. Children involved in the study will be assessed for emergence agitation within 30 minutes after recovery. Additional evaluations include perioperative anxiety during transfer to the operating room, mask tolerance during surgery, pain levels, and postoperative analgesic use up to 6 hours after surgery. Researchers monitor these outcomes alongside safety data during the trial period, which runs from July 2025 to July 2027.
CONDITIONS
Brief Title
Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 3 and 7 years
- Both sexes
- Classified as American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective adenotonsillectomy under general anesthesia
You will not qualify if you...
- Parental refusal to participate in the study
- Known allergy or hypersensitivity to dexmedetomidine, melatonin, or midazolam
- Presence of developmental delay
- Central nervous system disorders
- Intellectual disability
- Neurological or psychiatric conditions associated with anxiety or agitation (e.g., cerebral palsy, epilepsy, separation anxiety disorder, attention-deficit/hyperactivity disorder)
- Current or recent treatment with anticonvulsants or sedative medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day around surgery
Participants receive one of three drug interventions before adenotonsillectomy surgery to study effects on emergence agitation and pain.
1 preoperative visit (in-person)
Duration - Up to 6 hours after surgery
Participants are observed for emergence agitation, anxiety, pain, and analgesic consumption after surgery until discharge.
1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
A
Amany A Eid, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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