Emergence DeliriumPhase 3MELA-PAEDNCT05541276
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
A Phase 3 study testing Melatonin and Isotonic sodium chloride solution in people with Emergence Delirium, run by Arash Afshari at 1 site in Denmark.
Trial summary
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Melatonin and Isotonic sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 676 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Jan 2025to 1 Apr 2027
- Phase
- Phase 3
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 1-6 years
- Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia
Who cannot join
- Any known allergy or contraindication to study treatment or excipåients
- Current daily medication with melatonin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
Copenhagen, Capital Region, 2100
Anne Louise B Garioud, MD, 0045 35456243, anne.louise.de.barros.garioud@regionh.dk
Arash Afshari, MD, PhD, 0045 35458749, arash.afshari@regionh.dk
About this study
Official title: MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.
- Conditions
- Emergence Delirium
- Being tested
- Melatonin, Isotonic sodium chloride solution
- Keywords
- Anesthesia, Melatonin, Sevoflurane, Postoperative Pain, Child, PONV
- Medical subject headings
- Emergence Delirium, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin for injection 1 mg/mL
Isotonic sodium chloride solutionDrug
Also called Normal saline
Sodium chloride 0.9 % for injection
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Participants receive melatonin solution for injection 1 mg/mL in a dosage of 0.15 mg/kg body weight as a single intravenous injection approximately 30 minutes before end of surgical procedure. Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Participants receive isotonic sodium chloride (9mg/mL) intravenously once approximately 30 minutes before end of surgical procedure in a volume equivalent to the melatonin group for the same weight. Receives: Drug: Isotonic sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation
Participants will be assessed on Watcha scale repeatedly ever 15 min during their stay at the Post-Anesthetic Care Unit. The variable is dichotomous: any score >2= "Yes" and no score <=2 = "No"
Measured: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Secondary outcomes (2)
Opioid consumption
The total amount of opioids administered for postoperative pain in the PACU will be evaluated as units of morphine equivalents per kg. No more than 35 % of the popu-lation is expected to receive postoperative opioids in a range of approximately 10-100 µg/kg.
Measured: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Non-serious Adverse Events (AE)
Any untoward medical occurrence not considered serious.
Measured: From enrolment to the trial until 24-hour follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start21 Jan 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 676 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arash Afshari
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt, University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Arash Afshari, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Arash L Afshari, MD, PhD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541276
- Sponsor's protocol ID
- 20211125
- Other IDs
- 2021-006464-24
- Acronym
- MELA-PAED
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
de Barros Garioud AL, Afshari A, Halgreen LR, Nielsen KO, Andersen LPK. Pharmacokinetics of Intravenous Melatonin in Preschool-Aged Pediatric Surgical Patients. Paediatr Anaesth. 2026 Jun 22. doi: 10.1002/pan.70248. Online ahead of print.
PubMed 42325096
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT05541276
- Acronym / sponsor ID
- MELA-PAED / 20211125
- Conditions
- Emergence Delirium
- Keywords
- Anesthesia, Melatonin, Sevoflurane, Postoperative Pain, Child, PONV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 676 participants (estimated)
- Lead sponsor
- Arash AfshariUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt, University of Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Sep 2022 (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.
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninParticipants receive melatonin solution for injection 1 mg/mL in a dosage of 0.15 mg/kg body weight as a single intravenous injection approximately 30 minutes before end of surgical procedure. |
| Placebo | Placebo comparator | Drug: Isotonic sodium chloride solutionParticipants receive isotonic sodium chloride (9mg/mL) intravenously once approximately 30 minutes before end of surgical procedure in a volume equivalent to the melatonin group for the same weight. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 1-6 years
- Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia
Key exclusion criteria (2 listed)
- Any known allergy or contraindication to study treatment or excipåients
- Current daily medication with 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 |
|---|---|---|
| MelatoninMelatonin for injection 1 mg/mL | Drug | Melatonin |
| Isotonic sodium chloride solutionAlso: Normal salineSodium chloride 0.9 % for injection | Drug | Placebo |
Primary outcome
Incidence of emergence agitation
Time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Participants will be assessed on Watcha scale repeatedly ever 15 min during their stay at the Post-Anesthetic Care Unit. The variable is dichotomous: any score >2= "Yes" and no score <=2 = "No"
2 secondary outcomes
Opioid consumption
Time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Non-serious Adverse Events (AE)
Time frame: From enrolment to the trial until 24-hour follow-up.
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 18 Aug 2026.
- Derived from this study: PubMed 42325096de Barros Garioud AL, Afshari A, Halgreen LR, Nielsen KO, Andersen LPK. Pharmacokinetics of Intravenous Melatonin in Preschool-Aged Pediatric Surgical Patients. Paediatr Anaesth. 2026 Jun 22. doi: 10.1002/pan.70248. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
Arash L Afshari, MD, PhD study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin and Isotonic sodium chloride solution in people with Emergence Delirium, run by Arash Afshari at 1 site in Denmark.
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 2 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 18 Aug 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anne Louise B Garioud, MD (+4535456243, anne.louise.de.barros.garioud@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence agitation (time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541276, which also lists 1 linked publication.
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 18 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.