Preoperative AnxietyNCT06489327
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
A study testing melatonin (Circadin ®) 0.2 mg/kg and melatonin (Circadin ®) 0.4 mg/kg in people with Preoperative Anxiety, run by Al-Azhar University at 2 sites in 2 countries.
Trial summary
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- melatonin (Circadin ®) 0.2 mg/kg and melatonin (Circadin ®) 0.4 mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jul 2026to 15 Dec 2026
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of either sex
- age from 4 to 14 years
- Patients with American society Anesthesiologist physical status I and II
- Patients undergoing elective surgeries
Who cannot join
- ASA more than III
- Drug allergy.
- Gastrointestinal disorders.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Facualty of Pharmacy, Al Azhar University
Cairo, Cairo Governorate, 11765
Neveen Kohaf, 01060383012, nevenabdo@azhar.edu.eg
Haider Hamza, M.D
Iraq1 site, 1 recruiting
- Recruiting
Al-Ayen Univerisity
Madīnat Bābil, Babel, 51015
Haider Hamza, M.D, +9647811593388, hussein.hussein@alayen.edu.iq
About this study
Official title: Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.
In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.
Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.
- Conditions
- Preoperative Anxiety
- Being tested
- melatonin (Circadin ®) 0.2 mg/kg, melatonin (Circadin ®) 0.4 mg/kg, placebo group
- Keywords
- preoperative anxiety, general anesthesia, major surgery, oral melatonin, placebo, premedication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin (Circadin ®) 0.2 mg/kgDrug
Patients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
melatonin (Circadin ®) 0.4 mg/kgDrug
Patients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
placebo groupDrug
Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1st group: melatonin 0.2 mg/kg group | Active comparator | patients will receive oral melatonin at a dose of 0.2 mg/kg Receives: Drug: melatonin (Circadin ®) 0.2 mg/kg |
| 2nd group: M04 groupmelatonin 0.4 mg/kg group | Active comparator | patients will receive oral melatonin at a dose of 0.4 mg/kg Receives: Drug: melatonin (Circadin ®) 0.4 mg/kg |
| 3rd group: placebo group | Placebo comparator | patients will receive oral placebo premedication Receives: Drug: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety
The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line.
Measured: 24 hours
Secondary outcomes (1)
preoperative sedation
The sedation level will be assessed using Ramsay Sedation Scale. It divides a patient's level of sedation into six categories ranging from severe agitation at 1 to deep coma at 6.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start12 Jul 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Ayen Iraqi University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
- Investigators
- Neveen Kohaf, ph.d, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489327
- Sponsor's protocol ID
- 042/2021/Babel
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared upon resealable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT06489327
- Acronym / sponsor ID
- 042/2021/Babel
- Conditions
- Preoperative Anxiety
- Keywords
- preoperative anxiety, general anesthesia, major surgery, oral melatonin, placebo, premedication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Al-Ayen Iraqi University
- Study start
- 12 Jul 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 5 Jul 2024 (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.
Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.
In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.
Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st group: melatonin 0.2 mg/kg group | Active comparator | Drug: melatonin (Circadin ®) 0.2 mg/kgpatients will receive oral melatonin at a dose of 0.2 mg/kg |
| 2nd group: M04 groupmelatonin 0.4 mg/kg group | Active comparator | Drug: melatonin (Circadin ®) 0.4 mg/kgpatients will receive oral melatonin at a dose of 0.4 mg/kg |
| 3rd group: placebo group | Placebo comparator | Drug: placebo grouppatients will receive oral placebo premedication |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients of either sex
- age from 4 to 14 years
- Patients with American society Anesthesiologist physical status I and II
- Patients undergoing elective surgeries
Key exclusion criteria (3 listed)
- ASA more than III
- Drug allergy.
- Gastrointestinal disorders.
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 |
|---|---|---|
| melatonin (Circadin ®) 0.2 mg/kgPatients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg. | Drug | 1st group: melatonin 0.2 mg/kg group |
| melatonin (Circadin ®) 0.4 mg/kgPatients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg. | Drug | 2nd group: M04 groupmelatonin 0.4 mg/kg group |
| placebo groupPatients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg. | Drug | 3rd group: placebo group |
Primary outcome
preoperative anxiety
Time frame: 24 hours
The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line.
1 secondary outcome
preoperative sedation
Time frame: 24 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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. data will be shared upon resealable request from the principal investigator
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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.
Neveen Kohaf, ph.d principal investigator
Al-Azhar University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin (Circadin ®) 0.2 mg/kg and melatonin (Circadin ®) 0.4 mg/kg in people with Preoperative Anxiety, run by Al-Azhar University at 2 sites in 2 countries.
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 3 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 6 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 2 sites in Egypt, Iraq. 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. Some participants in this study may receive a placebo. 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 Neveen Kohaf, Ph.D (01060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative anxiety (time frame: 24 hours). 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 6 Jan 2026.