E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Emergence delirium Postoperative agitation |
Postoperativ agitation |
|
E.1.1.1 | Medical condition in easily understood language |
Agitation after surgery |
Uro efter kirurgi |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050233 |
E.1.2 | Term | Delirium on emergence |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this clinical trial is to investigate the prophylactic effects and safety of intrave-nous melatonin administered intraoperatively for prevention of postoperative agitation and emergence delirium in children after an elective surgical procedure. |
Formålet med forsøget er at undersøge, om melatonin givet i en blodåre kan forebygge uro efter kirurgi og er sikkert at anvende hos børn, der undergår en planlagt kirurgisk procedure. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The MELA-PAED trial: pharmacokinetic substudy. The objective of this sub-study is to perform pharmacokinetic profiling for intravenous melatonin in children 1-6 years of age. |
MELA-PAED studiet: farmakokinetisk delstudie. Formålet med dette delstudie er at udregne farmakokinetiske parametre for intravenøs melatonin hos børn på 1-6 år. |
|
E.3 | Principal inclusion criteria |
- Patients aged 1-6 years - Elective surgical procedure of an expected duration of at least 30 minutes in general anesthesia maintained with sevoflurane |
- Patienter 1-6 år - Planlagt kirurgisk procedure på mindst 30 minutter i fuld narkose vedligeholdt med sevofluran |
|
E.4 | Principal exclusion criteria |
- Any known allergy or contraindication to study treatment or excipients - Current daily medication with melatonin |
- Kendt allergi eller anden kontraindikation til forsøgmedicin eller hjælpestoffer - Aktuel daglig behandling med melatonin |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Emergence agitation: Incidence of emergence agiation will be evaluated on the Watcha scale. Emergence agitation is defined as any observation of a Watcha-score >2. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessment is carried out every 15 minutes from arrival in the post-anesthetic care unit until discharge therefrom, ususally within 4 hours. |
|
E.5.2 | Secondary end point(s) |
- Opioid consumption: The total amount of opioid needed for postoperative pain in post-anesthetic care unit will be evaluated as units of morphine equivalents per kg. - Non-serious adverse events: Any untoward medical occurence not considered serious (according to ICH-GCP definitions). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Opiod consumption is evaluated from arrival in the post-anesthetic care unit until discharge therefrom, usually within 4 hours. - Non-serious adverse events are evaluated from intervention until last follow-up interview after 24 hours. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |