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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07345715
- Acronym / sponsor ID
- 36265MD430/6/25
- Conditions
- Oral Melatonin, Nebulized Dexmedetomidine, Emergence Agitation, Children, Adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C (Control Group) | Active comparator | Drug: Normal salineParticipants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice. |
| Melatonin Group | Experimental | Drug: Oral melatonin syrupParticipants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup. |
| Dexmedetomidine Group | Experimental | Drug: Nebulized dexmedetomidineParticipants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineParticipants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice. | Drug | Group C (Control Group) |
| Oral melatonin syrupParticipants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup. | Drug | Melatonin Group |
| Nebulized dexmedetomidineParticipants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml. | Drug | Dexmedetomidine Group |
Primary outcome
Emergence agitation
Time frame: 30 minutes after recovery
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.
4 secondary outcomes
Perioperative anxiety
Time frame: During transferring to operating room (Up to 30 minutes).
Mask tolerance
Time frame: Intraoperatively
Degree of pain
Time frame: Before home discharge (Up to 6 hours)
Total postoperative analgesics consumption
Time frame: Before home discharge (Up to 6 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Oral Melatonin
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Not yet recruiting
Oral Melatonin as Adjunctive Therapy in Adults With Atopic Dermatitis
Atopic Dermatitis
Not yet recruiting
Locally Delivered Melatonin Gel in Management of Stage II Grade B Periodontitis
Periodontal Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany A Eid, MSc (00201012301802, amany.kamel@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence agitation (time frame: 30 minutes after recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.