E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post operative pain |
Postoperativ smärta |
|
E.1.1.1 | Medical condition in easily understood language |
Post operative pain |
Postoperativ smärta |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051059 |
E.1.2 | Term | Oral surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036237 |
E.1.2 | Term | Post operative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 evaluate effect of preemptive s-ketamine in subanesthetical dosage on acute and chronical post operative pain in third molar sugery. |
Att utvärdera effekten och tolererbarheten av preoperativ intravenös
tillförsel av s-ketamin i subanestetiska doser med avseende på akut
postoperativ smärta och utvecklingen av långvarig postoperativ smärta efter visdomstandskirurgi. |
|
E.2.2 | Secondary objectives of the trial |
To identify biomarkers that predicts or variates in association with pain experience.
To study the risk of developing chronical pain after third molar sugery |
Att söka efter biomarkörer som kan prediktera och/eller samvariera med patientens smärta efter visdomstandskirurgi.
Kartlägga förekomst av långvarig postoperativ smärta efter |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy or mild systemic disease (ASA I or II)
Age 18-44 years
Body weight: 50-100kg |
Frisk eller mild välkompenserad systemsjukdom (ASA I & II)
18-<45 år
50-100 kg kroppsvikt |
|
E.4 | Principal exclusion criteria |
Medication: analgetics, hypnotics (the last week before inclusion),
thyroid hormones, psychopharmaceutics or MAO-inhibitors.
Hypertension [>150/95 mmHg at screening ]
Heartfailure
Psychosis
Epilepsy
Hyperthyreosis
Myastenia gravis
Glaukoma
Sleepapnea
Diabetes (Type I)
Porfyria
Pregnancy
Nursing
Blood disease (Hepatitis A, B and HIV)
Unable to understand spoken or written information in swedish
Known allergy against: midazolam, ketamine, ibuprofen, or local
anesthesia |
Medicinering med: analgetika, hypnotika (närmaste veckan före
operationen), thyroideahormoner, psykofarmaka eller MAO-hämmare.
Hypertoni [>150/95 mmHg vid screening undersökning]
Hjärtsvikt
Psykossjukdom
Epilepsi
Hyperthyreos
Myastenia gravis
Glaukom/grönstarr
Verifierad sömnapné
Diabetes (insulinbehandlad)
Porfyri
Graviditet
Amning
Blodsmitta
Oförmögenhet att tillgodogöra sig erforderlig skriftlig och eller muntlig
information
Känd överkänslighet mot midazolam, ketalar, ibuprofen, eller
lokalanestesimedel |
|
E.5 End points |
E.5.1 | Primary end point(s) |
VAS registration during the first 24h post operative |
VAS-registrering av smärta (första 24 postoperativa timmarna) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of inclusion |
Vid avslutad inklusion |
|
E.5.2 | Secondary end point(s) |
Pain questionaire (by Telephone) |
Smärtenkät (telefon) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months post operative |
6 månader postoperativt |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | 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 | Yes |
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
|
The last visit of the last subject undergoing the trial n=165 |
Sista besöket av den sista deltagaren när inklusionen uppnåtts och
n=165 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |