Oral MelatoninNCT07345715
Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy
A study testing Normal saline, Oral melatonin syrup and Nebulized dexmedetomidine in people with Oral Melatonin and Nebulized Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation
- What is being tested?
- Normal saline, Oral melatonin syrup and Nebulized dexmedetomidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 3 and 7 years.
- Both sexes.
- Classified as American Society of Anesthesiologists (ASA) physical status I or II according to the American Society of Anesthesiologists.
- Scheduled for elective adenotonsillectomy under general anesthesia.
Who cannot join
- 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 (formerly termed mental retardation).
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Amany A Eid, MSc, 00201012301802, amany.kamel@med.tanta.edu.eg
Nagat S Elshamaa, MD
About this study
Official title: Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
Read the detailed description
Adenotonsillectomy is one of the most commonly performed surgical procedures in children with high incidence of emergence agitation about 80% and high degree of post operative pain.
Oral midazolam, a short-acting benzodiazepine, is commonly used as a standard premedication in children due to its well-established anxiolytic, sedative, and amnestic effects. It works by enhancing GABAergic neurotransmission in the central nervous system, helping reduce anxiety and facilitating a smoother anesthetic induction and emergence.
Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action.
- Conditions
- Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation, Children, Adenotonsillectomy
- Being tested
- Normal saline, Oral melatonin syrup, Nebulized dexmedetomidine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.
Oral melatonin syrupDrug
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
Nebulized dexmedetomidineDrug
Participants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Control Group) | Active comparator | Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice. Receives: Drug: Normal saline |
| Melatonin Group | Experimental | Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup. Receives: Drug: Oral melatonin syrup |
| Dexmedetomidine Group | Experimental | Participants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml. Receives: Drug: Nebulized dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of ≥10 has 64% sensitivity and 86% specificity for the diagnosis of Emergence Agitation (ED). A score of >12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED.
Measured: 30 minutes after recovery
Secondary outcomes (4)
Perioperative anxiety
Perioperative anxiety which will be measured by using Parental separation anxiety scale (PSAS).
PSAS scale:
- Excellent: Patient unafraid, cooperative, or asleep.
- Good: Slight fear and or crying, quiet with reassurance.
- Fair: Moderate fear and crying, not quiet with reassurance.
- Poor: Crying, need for restraint. Score of 1 or 2 were classified as an acceptable separation, whereas scores of 3 or 4 were considered difficult separations from the parents.
Measured: During transferring to operating room (Up to 30 minutes).
Mask tolerance
Mask tolerance which will be measured by using mask acceptance scale (MAS).
MAS score:
- Excellent: calm, cooperative, or asleep.
- Good: Moderate fear of the mask Manageable with reassurance.
- Fair: Cries, combative and needs restraining.
- Poor: Crying, need for restraint. Score of 1 or 2 were classified as an acceptable mask tolerance, whereas scores of 3 or 4 were considered poor mask tolerance.
Measured: Intraoperatively
Degree of pain
Postoperative pain control will be assessed using Face, Legs, Activity, Cry, Consolability (FLACC) ) on arrival to PACU, 30 minutes, one hour, two hours after surgery and before home discharge.
Each category is scored on the 0-2 scale, which results in a total score of 0-10.
- 0 = Relaxed and comfortable.
- 1-3 = Mild discomfort.
- 4-6 = Moderate pain.
- 7-10 = Severe discomfort/pain.
Measured: Before home discharge (Up to 6 hours)
Total postoperative analgesics consumption
Total postoperative analgesics consumption will be recorded.
Measured: Before home discharge (Up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MelatoninStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Abd Elsamd Kamel Eid, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345715
- Sponsor's protocol ID
- 36265MD430/6/25
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.