E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain syndrome in 7 to 18 years old children with acute uncomplicated appendicitis, who received non-surgical treatment. |
Sāpju sindroms bērniem vecumā no 7 līdz 18 gadiem ar akūtu nekomplicētu apendicītu neķirurģiskās ārstēšanas gadījumos. |
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E.1.1.1 | Medical condition in easily understood language |
Severity of pain in 7 to 18 years old children with acute uncomplicated appendicitis, who received treatment without surgical operation. |
Sāpju stiprums bērniem vecumā no 7 līdz 18 gadiem ar akūtu nesarežģītu aklās zarnas tārpveida piedēkļa iekaisumu, kuri saņēma ārstēšanu bez operācijas. |
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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 |
To perform a study of pain syndrome and clinical-biochemical parameters in 7 to 18 years old children with uncomplicated acute appendicitis in non-surgical treatment and develop an analgesic algorithm based on the obtained data. |
Sāpju sindroma un klīniski-bioķīmisko parametru izpēte bērniem no 7 līdz 18 gadu vecumam ar nekomplicētu akūtu apendicītu neķirurģiskas ārstēšanas gadījumos un pretsāpju algoritma izstrāde, pamatojoties uz iegūtajiem datiem.
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Nav piemērojams |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
7 to 18 years old children with first time diagnosed uncomplicated acute appendicitis who received non-surgical treatment. |
Bērni vecumā no 7 līdz 18 gadiem ar pirmreizēji diagnosticētu nekomplicētu akūtu apendicītu neķirurģiskās ārstēšanas gadījumos. |
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E.4 | Principal exclusion criteria |
Psychomotor retardation of any degree; Any inherited or acquired immunodeficiency; Any abdominal surgery in medical history; Neurological deficit of any degree; Any endocrine disease; NSAID use within 3 hours; Chronic pain requiring daily analgesic use; History of gastrointestinal bleeding, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations; History of chronic and active renal disease, excluding renal calculi and urinary tract infections; History of chronic and active hepatocellular disease (excludes biliary stones, cholangitis or biliary duct pathology); Known hypersensitivity to ketorolac (or it's component) or other NSAID; Absence of a parent/guardian for children who are < 14 years in age. |
Jebkuras pakāpes psihomotorās attīstības aizture; Jebkurš iedzimts vai iegūts imūndeficīts; Jebkura abdominālā ķirurģija anamnēzē; Jebkuras pakāpes neirodeficīts; Jebkura endokrīnā saslimšana; NSPIL invade pēdējās 3 stundās; Hroniskās sāpes ar analgēzijas līdzekļu ikdienas lietošanu; Anamnēzē gastrointestinālā asiņošana, peptiskā vai duodenāla čūla, iekaisīgā zarnu slimība, asinsreces traucējumi, cerebrovaskulārā asiņošana, arteriovenozā malformācija; Anamnēzē hroniska un aktīva nieru slimība, izņemot nefrokalcinozi un urīnceļu infekciju; Anamnēzē hroniska un aktīva hepatocellulāra slimība, izņemot žults ceļu patoloģiju; Zināma hipersensitivitāte pret ketorolaku (vai tā sastāvdaļām) vai cita NSPIL; Vecāku vai likumīgo aizbildņu prombūtne/trūkums. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients consented from total approached; Number of patients who completed pain assessment and treatment at all time points (totally for 3 days (72 hours)); |
Piekritušo pacientu skaits no kopējā; Pacientu skaits, kuriem visos laika posmos pabeidza sāpju novērtēšanu un ārstēšanu (kopumā 3 dienas (72 stundas)); |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1-3: in-patient treatment; |
1.-3.diena: ārstēšana stacionārā; |
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E.5.2 | Secondary end point(s) |
Not applicable |
Nav piemērojams |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Nav piemērojams |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 11 |
E.8.9.1 | In the Member State concerned days | 25 |