Overview
Sponsor-declared trial summary
Emergence delirium
The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postoperative agitation and emergence delirium in children after an elective surgical procedure.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 30 May 2026 → ongoing
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Oberstinde Kirsten Jensa la Cours Legat · Rigshospitalet Research Grants · Lægeforeningens Forskningsfond · Lippmann Fonden · Dagmar Marshalls Fond · DASAIM Research Initiative · Sundhedsdonationer · Kong Christian den Tiendes Fond
External identifiers
- EU CT number
- 2024-517592-20-00
- EudraCT number
- 2021-006464-24
- ClinicalTrials.gov
- NCT05541276
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Efficacy, Pharmacokinetic, Safety
The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postoperative agitation and emergence delirium in children after an elective surgical procedure.
Conditions and MedDRA coding
Emergence delirium
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10050233 | Delirium on emergence | 10022117 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients aged 1-6 years
- Elective surgical procedure of an expected duration of at least 30 minutes in general anesthesia
Exclusion criteria 2
- Any known allergy or contraindication to study treatment or excipients
- Current daily medication with melatonin
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Emergence agitation
Secondary endpoints 2
- Opioid consumption
- Non-serious adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11648994 · Product
- Active substance
- Melatonin
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 0.15 mg/kg milligram(s)/kilogram
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REGION HOVEDSTADENS APOTEK
- Paediatric formulation
- Yes
- Orphan designation
- No
Placebo 1
Natriumklorid Fresenius Kabi 9 mg/ml
PRD2503457 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.15 millilitre(s)/kilogram
- Max total dose
- 5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 17927
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Arash Afshari
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Anne Louise de Barros Garioud
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 676 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-01-10 | 2025-01-20 | 2025-07-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-89798
- Halt date
- 2025-07-09
- Member states concerned
- Denmark
- Publication date
- 2025-07-09
- Reason
- Medicinal Product related
- Explanation
- We have concluded the first open-label pharmacokinetic part of the trial. We are currently preparing a SM to prolong shelf-life of our IMP with an updated IMPD. In the meantime, we are not initiating enrolment in the blinded, randomized part of the trial to facilitate relabelling of the full batch current batch due to expire later this year.
- Follow-up measures
- None
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | D1_Statistical Analysis Plan 2024-517592-20 clean | 2.0 |
| Protocol (for publication) | D1_Protocol 2024-517592-20 Public | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements ph | 1 |
| Subject information and informed consent form (for publication) | L1_ICF RCT tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS pK substudy | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS RCT | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Participant rights | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2024-517592-20 | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-24 | Denmark | Acceptable 2024-11-08
|
2024-11-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-09 | Denmark | Acceptable 2025-10-17
|
2025-10-17 |