E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative agitation |
Opvågningsdelir/agitation efter generel anæstesi |
|
E.1.1.1 | Medical condition in easily understood language |
Agitation or delirium after awakening from anaesthesia is, in particular, a challenge with preschool children |
Agitation eller delirium i forbindelse med opvågning efter bedøvelse, som er en særlig hyppig og stor udfordring hos børn i førskolealderen. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001499 |
E.1.2 | Term | Agitation mental |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056436 |
E.1.2 | Term | Psychomotor agitation |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10079742 |
E.1.2 | Term | Agitation on recovery from sedation |
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 |
To examine if postoperative agitation can be reduced when giving optimal analgesics and dexmedetomidine while the patient is under general anaesthesia. The primary outcome measure is a Richmond agitation and sedation score. |
Formålet med dette projekt er at undersøge om opvågningsdelir kan reduceret ved opitmereret smertestillende behandling og dexmedetomidine. Primære outcome er Richmond agitation and sedation score. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children allocated for general anaesthesia in abdominal and urology setup. ASA 1-2. Consent from both parents/legal representatives |
Børn allokeret til generel anæstesi i abdominalt eller urologisk setup, ASA 1-2. Samtykke fra begge forældre/representativer |
|
E.4 | Principal exclusion criteria |
ASA > 2, age >1 and < 6 years. Missing consent from parents/legal surrogates. Expected short-term procedures. Daily use of analgesics. Known allergies or intolerances to dexmedetomidine or remifentanil. Intubation. Furthermore, patients with parents that do not speak and write Danish fluently will be excluded too. |
ASA >2 og >1 og< 6 år. Manglende samtykke fra forældre/representative. Forventede kortvarige procedurer. Dagligt forbrug af smertestillende. Kendte allergier til dexmedetomidine eller remifentanil. Intubation. Ikke dansktalende forældre/representative. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Postoperative observation unit from just after awakening from anaesthesia and until leaving the hospital |
I det postoperative forløb fra lige efter opvågning og indtil familien forlader hospitalet |
|
E.5.2 | Secondary end point(s) |
Time, PONV, FLACC scale score, PAED score, nurse-NRS, parent-NRS, consumption of pain medications 24 hours postoperatively, total fentanyl dosage, total remifentanil dosage, propofol dosage. Events such as surgical stimuli, incision, cough, movement, and skin suture, in relation to ANI values. |
Tidsforbrug, PONV, FLACC scale score, PAED score, sygeplejeske-NRS, forældre-NRS, forbrug af smertestillende medicin 24 timer postoperativt, fentanyldosis, remifentanildosis, propofoldosis. Events såsom kirurguisk stimuli, insicion, hoste, bevægelse og hudsutur i relation til ANI-værdie |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
In the postoperative awakening phase and as a questionnaire/phone interview 24 hours after anaesthesia |
I det postoperative forløb og som et spørgeskema/telefoninterview 24 timer efter bedøvelsen |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
|
1. October 2023 |
1. oktober 2023 |
|
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 | |