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 lacerations that require suturing , 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 |
The aim of this study is to measure whether intranasal dexmedetomidine can provide better, faster onset of action and more effective, analgesia and sedation during procedure than intranasal S-ketamine among children between 1 and 3 years of age with minor injuries with respect to analgesia measured by FLACC in a prospective randomized doubleblind study. We are interested in finding out if intranasal dexmedetomidine could be used for PSA for painful procedures in combination with local anesthesia. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children at the age of 1 - 3 years who present to the emergency department - A laceration in need of suturing or burn less than 4% of body surface area - Weight 10 – 15 kg - Previously healthy - Swedish speaking |
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E.4 | Principal exclusion criteria |
•ASA classification ≥ III (see Supplement 12) •Current respiratory tract infection •Impaired level of consciousness •Hypersensitivity for dexmedetomidine or S-ketamine. •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. - advanced heart block (grade 2 or 3) unless paced - uncontrolled hypotension - 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 sedation. Pain will be assessed by trained ED nurses with FLACC (Face, Legs, Activity, Cry, Consolability) scale and change of 2 points on the scale of 0-10 is considered as significant change. |
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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 scale20 will be used. A change of 1 point on the scale of 1-6 is considered as significant change. |
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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 | 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) | 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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |