E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
sedation for emergency procedures |
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E.1.1.1 | Medical condition in easily understood language |
sedation for procedures (for example fracture reduction, burn dressing) in the emergency department |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
Aim of this study is to measure whether intranasal dexmedetomidine is equally good as nitrous oxide (N2O) among children between 3 and 15 years of age with minor injuries with respect to analgesia during procedure measured by FLACC in a prospective randomized open-label study. We are interested in finding out if dexmedetomidine could be used for PSA for painful procedures in combination with local anesthetics.
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E.2.2 | Secondary objectives of the trial |
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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 |
Observational and interview study to better understand patiens experience about the PSA. |
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E.3 | Principal inclusion criteria |
Children at the age of 3 - 15 years who present to the emergency department • extremity fracture/luxation that require reduction or burn less than 4% of body surface area • Previously healthy (ASA I and II) • Swedish speaking
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E.4 | Principal exclusion criteria |
• ASA classification ≥ III (see Supplement 11) • Current respiratory tract infection • Ear infection • Sinusitis • Pertussis within 6 months • Any symptoms of breathing difficulty • Active and uncontrolled vomiting • Impaired level of consciousness • Psychiatric issues • Hypersensitivity for dexmedetomidine or N2O. • Further contraindications named in the product resume for the trial medicines would categorize the patient as ASA III and therefore not suitable for this trial. o advanced heart block (grade 2 or 3) unless paced o uncontrolled hypotension o acute cerebrovascular conditions.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome is pain during the procedure, pain during the procedure compared to the pain before. Pain will be assessed with FLACC27 (Face, Legs, Activity, Cry, Consolability scale) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pain (FLACC) assessment - at 0 – 5 – 10 min from administration of study medicine and continue every 5 minutes until Ramsay score 2 is reached - at the start of the procedure and every 5min under the procedure - after procedure every 10 minutes until the patient has recovered and reached Ramsay score 1
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E.5.2 | Secondary end point(s) |
The secondary outcome is sedation, patient's/guardian's satisfaction and doctor's opinion about the feasibility of the procedure. Patient/guardian(s) will receive a questionnaire with few questions. Doctor's opinion will be recorded on the CRF. To assess the sedation Ramsay sedation scale will be used. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Sedation (Ramsay score) assessment - at 0 – 5 – 10 min from administration of study medicine and continue every 5 minutes until Ramsay score 2 is reached - at the start of the procedure and every 5min under the procedure - after procedure every 10 minutes until the patient has recovered and reached Ramsay score 1 Questionaries will be filled after the procedure. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |