E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain on i v cannulation |
Smärta vid perifer venkanylering |
|
E.1.1.1 | Medical condition in easily understood language |
Needle-stick pain on insertion of plastic tube into blood vessel |
Smärta vid insättning av droppslang i blodkärl (venkanylering) |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
MedDRA Classification |
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 primary aim is to determine if buccal dexmedetomidine reduces the pain reaction associated with peripheral vein cannulation in neonates. |
Utröna om buckalt deponering av dexmedetomidine reducerar smärtreaktionen vid perifer venkanylering |
|
E.2.2 | Secondary objectives of the trial |
The secondary aim is to evaluate the safety of buccal admininstration of dexmedetomidine in neonates and obtain premininary pharmacokinetic data on. |
Att evaluera säkerhetsprofilen för buckalt dexmedetomidin hos nyfödda samt att få preliminära farmakokinetiska data. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Neonate admitted to neonatal intensive care unit or high dependency unit at Uppsala University Hospital 2. Planned insertion of a peripheral i v cannula or PICC, when a painful procedure is anticipated due to e g previous difficult i v access
|
1. Behov av neonatal intensivvård 2. Venkanylering planerad, där proceduren befaras vara smärtsam t ex pga tidigare besvärlig kanylering |
|
E.4 | Principal exclusion criteria |
Age < 33 gestational weeks or > 44 gestational weeks Weight < 1 kg or > 5 kg Opioid, alpha-2-agonist or anaesthetic given within 12 hours of study start Planned discharge within 24 hour after intervention |
Gestationsålder < 33 respektive > 44 veckor. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Significant difference in pain score assessment (N-PASS) between the groups |
Skillnad i smärtskattning (N-PASS) mellan grupperna |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessment will be performed 5 minutes before the start of the procedure, at the time of the first attempt of vein cannulation and at every subsequent attempt as applicable, and five minutes after the end of the procedure. |
N-PASS bedöms 5 minuter före, under venkanylering samt fem minuter efter venkanylering |
|
E.5.2 | Secondary end point(s) |
Change in skin conduction Change in blood pressure > 20% from baseline Bradycardia – heart rate < 100 bpm Hypoventilation leading to SpO2 < 90%
|
Skillnad i hudkonduktans eller NIRS mellan grupperna Blodtryckförändring > 20% från baslinjen Bradykardi - puls < 100 Hypventilation som leder till SpO2 < 90%
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Skin conductance and NIRS: as for primary endpoint. Blood pressure, heart rate, saturation and breath rate: continuously for 12 hours after intervention |
Hudkonduktans och NIRS: som för primär endpoint. Blodtryck, puls, saturation och andning: under 12 timmar efter kanylering |
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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 | 3 |
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
|
LVLS |
Sista patienten inkluderad |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |