E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pediatric patients receive ilioinguinal-iliohypogastric nerve blockade with 0.2ml/kg ropivacaine 0.197% and 0.3µg/kg dexmedetomidine or 0.2ml/kg ropivacaine 0.197% and saline as a placebo. Aim of the study is to investigate if dexmedetomidine as an adjuvant to local anaesthetics prolongs the duration of the block and furthermore reduces the postoperative pain therapy or at least delay the first application of analgetic drugs. |
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E.1.1.1 | Medical condition in easily understood language |
Paediatric patients receive a special abdominal nerve block as a pain therapy for operations. Dexmedetomidine as an adjuvant to local anesthetics should prolong the blockade and reduce analgesia.
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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 main objective of this study is to investigate if paediatric patients could have a benefit from dexmedetomidine |
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E.2.2 | Secondary objectives of the trial |
Dexmedetomidine as an adjuvant to local anaesthetic reduces alterations in feeding and sleeping habits |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Paediatric outpatients undergoing hernia operation •Aged between 6months and 8 years •Written informed consent given by parents/legal guardian after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug
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E.4 | Principal exclusion criteria |
•Contraindication to a peripheral nerve block e.g. local skin infection at the site of nerve block injection, known allergy against local anaesthetics, severe coagulopathy, local anatomical abnormality •Participation in another clinical study within the last 4 weeks prior to study •Lack of parents´ cooperation and language difficulties •Other objections to participate in the study in the opinion of the investigator •BMI>30kg/m2
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E.5 End points |
E.5.1 | Primary end point(s) |
Dexmedetomidine as an adjuvant to local anesthetic prolongs the duration of an ilioinguinal iliohypogastric nerve block in paediatric patients and reduces the need of postoperative pain therapy. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
•3 hours postoperative in PACU by nurse •6 hours postoperative at home by parents •12 hours postoperative at home by parents •24 hours postoperative at home by parents •Sleeping interruption (if differs from daily routine) •Denying of feeding
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E.5.2 | Secondary end point(s) |
Dexmedetomidine as an adjuvant to local anesthetic causes less alteration in daily routine relating to sleeping and feeding habits |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
•3 hours postoperative in PACU by nurse •6 hours postoperative at home by parents •12 hours postoperative at home by parents •24 hours postoperative at home by parents •Sleeping interruption (if differs from daily routine) •Denying of feeding
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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) | 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
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The last telephone interview with the parents takes place 24hours postoperatively. After this call the study is finished. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |