Post Tonsillectomy Emergence AgitationNCT07375342
Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric
A study testing Melatonin in people with Post Tonsillectomy Emergence Agitation, run by Benha University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are: Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Post Tonsillectomy Emergence Agitation
- What is being tested?
- Melatonin
- 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
- 1 siteEgypt
- Study dates
- 10 Dec 2025to 1 Aug 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
- American Society of Anesthesiologists (ASA) physical status I or II.
- Parent/legal guardian provides written informed consent
Who cannot join
- • Known allergy or contraindication to melatonin.
- Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD).
- Children receiving any sedative or psychoactive medication within 48 hours of surgery.
- Emergency surgery or any procedure other than tonsillectomy/adenoidectomy.
- Children with known sleep disorders or those taking melatonin supplements.
- Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively.
- Hepatic or renal dysfunction (ALT/AST >2×ULN, Cr >1.5 mg/dL)
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
Benha University Hospital
Banhā
Taghreed Sakr, MD degree of anesthesia, 00201112723187, taghreed.sakr@fmed.bu.edu.eg
About this study
Official title: Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are:
Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy
Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.
- Conditions
- Post Tonsillectomy Emergence Agitation
- Being tested
- Melatonin, Placebo
- Keywords
- agitation, tonsillectomy, pediatric
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
PlaceboDrug
Participants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia.
The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration,
| Study group | Role | What they receive |
|---|---|---|
| Group M (Melatonin Group) | Active comparator | Not described Receives: Drug: Melatonin |
| Group P (Placebo Group) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
The PAED scale consists of five items (eye contact, awareness of surroundings, purposeful actions, restlessness, and inconsolability), each scored from 0 to 4. Total score ranges from 0 to 20., scale ≥10 or equivalent define the presence of clinically significant EA
Measured: 5, 10, 15, and 30 minutes after arrival in the PACU.
Secondary outcomes (5)
Time to Discharge
Measured as the time from PACU arrival to achieving a modified Aldrete score (a 10-point system used in the post-anesthesia care unit (PACU) to assess a patient's recovery and determine if they are ready for discharge. It evaluates five categories: Activity, Respiration, Circulation, Consciousness, and Oxygen saturation. Each category is scored from 0 to 2, and a total score of 9 or 10 generally indicates that the patient can be safely discharged from the PACU). ≥9 (min),
Measured: 10-30 min from arriving to PACU
Postoperative Pain
Assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at the same time points as the PAED scale.
Measured: first 2 hours postoperative
Rescue Analgesia
Total dose of rescue analgesia (e.g., intravenous morphine or fentanyl measured according to the child weight in kg ) required in the PACU.
Measured: 24 hours after surgery
Adverse Events
Incidence of PONV, respiratory depression (defined as {SpO}_2 < 90% requiring intervention), bradycardia (<60 bpm), intraoperative hemodynamic instability excessive sedation (Ramsay Sedation Scale > 3) and other adverse events.
Measured: first 24-hour post operative
Parent/caregiver satisfaction
measured at discharge (Likert scale) used to measure attitudes, opinions, and behaviors by asking respondents to rate their level of agreement or intensity of feeling regarding a statement, it include options such as strongly disagree, disagree, somewhat disagree, either agree or disagree, somewhat agree, and agree
Measured: first 24-hour post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start10 Dec 2025
- Primary completion1 May 2026
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Tonsillectomy Emergence AgitationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghreed Elshahat Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375342
- Sponsor's protocol ID
- RC.2.11.2025
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07375342
- Acronym / sponsor ID
- RC.2.11.2025
- Conditions
- Post Tonsillectomy Emergence Agitation
- Keywords
- agitation, tonsillectomy, pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 29 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.
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are:
Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy
Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M (Melatonin Group) | Active comparator | Drug: Melatonin |
| Group P (Placebo Group) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I or II.
- Parent/legal guardian provides written informed consent
Key exclusion criteria (7 listed)
- • Known allergy or contraindication to melatonin.
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 |
|---|---|---|
| MelatoninParticipants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration, | Drug | Group M (Melatonin Group) |
| PlaceboParticipants will receive an identical placebo tablet administered 30 minutes before induction of anesthesia. The tablet will be crushed and mixed with a small amount of water or juice to facilitate administration, | Drug | Group P (Placebo Group) |
Primary outcome
Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
Time frame: 5, 10, 15, and 30 minutes after arrival in the PACU.
The PAED scale consists of five items (eye contact, awareness of surroundings, purposeful actions, restlessness, and inconsolability), each scored from 0 to 4. Total score ranges from 0 to 20., scale ≥10 or equivalent define the presence of clinically significant EA
5 secondary outcomes
Time to Discharge
Time frame: 10-30 min from arriving to PACU
Postoperative Pain
Time frame: first 2 hours postoperative
Rescue Analgesia
Time frame: 24 hours after surgery
Adverse Events
Time frame: first 24-hour post operative
Parent/caregiver satisfaction
Time frame: first 24-hour post operative
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 17 Jul 2026.
- Individual participant dataSharing planned: No
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 Melatonin in people with Post Tonsillectomy Emergence Agitation, run by Benha 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 2 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 17 Jul 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (time frame: 5, 10, 15, and 30 minutes after arrival in the PACU.). 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 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.