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    Summary
    EudraCT Number:2013-003220-36
    Sponsor's Protocol Code Number:45112
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003220-36
    A.3Full title of the trial
    Remifentanil use for procedural sedation and analgesia in the emergency department
    Remifentanil voor procedurele sedatie en analgesie op de spoedeisende hulp
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Remifentanil use for sedation and pain managment during a painful treatment at the emergency department.
    Gebruik van remifentanil voor sedatie en pijnbestrijding bij pijnlijke ingrepen op de
    spoedeisende hulp
    A.4.1Sponsor's protocol code number45112
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlbert Schweitzer hospital
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlbert Schweitzer hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlbert Schweitzer hospital
    B.5.2Functional name of contact pointMartijn van Hooft
    B.5.3 Address:
    B.5.3.1Street AddressSchweitzerplaats 25 / Postbus 444
    B.5.3.2Town/ cityDordrecht
    B.5.3.3Post code3300 AK
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031786545393
    B.5.6E-mailm.van.hooft@asz.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ultiva (remifentanil)
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithkline
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameultiva
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Diprivan (propofol)
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDiprivan
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fentanyl
    D.2.1.1.2Name of the Marketing Authorisation holderHameln Pharmaceuticals GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFentanyl Bipharma
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The research will be conducted in patients that need short painfull treatment in the emergency department and with an indication for PSA. These treatments include: repositioning of fractures, repositioning of luxation, abcess incision and drainage, wound care, chest drain, electrical cardioversion. We want to find out if remifentanil is a usefull medication for PSA in the emergency department and is the recovery time shorter compared with the frequently used combination fentanyl / propofol.
    Het onderzoek zal worden uitgevoerd bij alle patiënten die een korte pijnlijke behandeling op de spoedeisende hulp nodig hebben met een indicatie voor PSA. Deze behandelingen zijn: repositie van fracturen, repositie van luxaties, abces incisie en drainage, wondverzorging, thoraxdrain, elektrische cardioversie. We willen weten of remifentanil een bruikbaar medicijn is voor PSA op de spoedeisende hulp en of de hersteltijd korter is vergeleken met de vaak gebruikte combinatie fentanyl / propofol.
    E.1.1.1Medical condition in easily understood language
    Research in patients who need sedation and analgesia during a painful treatment in the emergency department. Is remifentanil a good option with short recovery compared to fentanyl/propofol?
    Onderzoek bij patiënten die sedatie en pijnstilling krijgen tijdens een pijnlijke ingreep op de spoedeisende hulp. Is remifentanil een goede optie met snel herstel vergeleken met fentanyl/propofol?
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Answering the following question.
    Is remifentanil a usefull medication for procedural sedation and analgesia (PSA) in the emergency department and is the recovery time shorter compared to the frequently used combination propofol / fentanyl?
    Beantwoorden van de volgende vraag.
    Is remifentanil een geschikt middel voor procedurele sedatie en analgesie (PSA) op de spoed eisende hulp en is de hersteltijd van de patiënt korter in vergelijking tot de veelgebruikte combinatie propofol / fentanyl?
    E.2.2Secondary objectives of the trial
    Answering the following questions.
    What is the recovery time of the patient when using fentanyl / propofol / remifentanil (time between last gift PSA medication and full recovery of the patient)?
    Is there a difference in the occurrence of adverse effects / complications such as desaturation / apnea / drop in blood pressure / nausea / vomiting compared to the use of fentanyl / propofol?
    Is the length of stay shortened with the use of remifentanil in relation to the use of fentanyl / propofol?
    Is the specialist satisfied about the treatment given during the procedure?
    How much is the pain experienced by the patient during the procedure?
    Is the patient satisfied after the treatment?
    Beantwoorden van de volgende vragen
    Wat is de hersteltijd van de patiënt bij gebruik van fentanyl/propofol/remifentanil (tijd tussen laatste gift PSA medicatie en volledig helder zijn van de patiënt)?
    Is er verschil in het optreden van nadelige effecten / complicaties zoals desaturatie / apneu / tensiedaling / misselijk / braken in vergelijking tot het gebruik van fentanyl/propofol?
    Is de ligduur verkort bij gebruik van remifentanil ten opzichte van het gebruik van fentanyl / propofol?
    Kan de behandeling tot tevredenheid van de specialist worden uitgevoerd?
    Wat is de pijnbeleving van de patiënt tijdens de procedure?
    Is de patiënt tevreden na de behandeling?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All the patients who need procedural sedation and analgesia (PSA) at the emergency department or the observatorium of the Albert Schweitzer hospital location Dordwijk in Dordrecht, age 18 years and older, classified as ASA I en II.
    Alle patiënten die procedurele sedatie en analgesie (PSA) ondergaan op de spoed eisende hulp dan wel het observatorium van het Albert Schweitzer ziekenhuis locatie Dordwijk in Dordrecht, vanaf 18 jaar en ASA I en II zijn geclassificeerd.
    E.4Principal exclusion criteria
    Age under 18 years, hemodynamic and/or respiratory instable, classified as ASA III, IV and V, suspicion of elevated intra-cranial pressure, pregnancy, use of opiates at home, opiates administered before PSA procedure started (in the ambulance, on arrival at the emergency department), intoxication, allergy for fentanyl propofol remifentanil soy or chicken proteins.
    Leeftijd onder de 18 jaar, hemodynamisch/respiratoir instabiele patiënt, ernstige co-morbiditeit ASA III, IV en V, verdenking verhoogde intra-craniele druk, zwangerschap, opiaten gebruik als thuismedicatie, opiaten toegediend niet onderdeel uitmakend van de PSA procedure, (door ambulance, direct bij binnenkomst op de SEH) intoxicatie, allergie voor fentanyl, propofol, remifentanil, soja of kippeneiwit.
    E.5 End points
    E.5.1Primary end point(s)
    The recovery time. (time between last dose PSA medication and full recovery of the patient).
    De hersteltijd (tijd tussen laatste gift PSA medicatie en volledig helder zijn van de patiënt).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After inclusion of 6o patients in this study.
    Nadat er 60 patienten in deze studie zijn geincludeerd.
    E.5.2Secondary end point(s)
    - Adverse effects, complications.
    - Succesfull interventions.
    - Satisfaction of the specialist about performing the intervention.
    - Adequate analgesia during procedure.
    - Satisfaction patient.
    - Nadelige effecten complicaties.
    - Succespercentage ingreep.
    - Tevredenheid van de specialist over het uitvoeren van de ingreep.
    - Adequate pijnstilling tijdens procedure.
    - Tevredenheid patiënt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 5 minutes before the procedure, the vital signs are checked every 5 minutes. Immediately after the procedure, the intervention is evaluated with the doctors involved and the patient. Also, the following information is listed on the registartieformulier:The medication and total dosage of analgesic, sedative, concomitant medications, antidote, other medications administered , additional O2 need, deepest Ramsay sedation score, occurrence of incidents / complication and various times (time start PSA, time start surgery, surgery end time, date last gift PSA medication, time patient fully recovers from PSA, patient discharge time).
    Vanaf 5 minuten voor aanvang van de procedure worden de vitale parameters iedere 5 minuten gecontroleerd. Direct na de procedure wordt de ingreep geevalueerd met de betrokken artsen en patient. Tevens worden de volgende gegevens genoteerd op het registartieformulier: de medicatie en totale dosering analgeticum, sedativum, co-medicatie, antidotum, overige medicatie toegediend, extra O2 behoefte, diepste Ramsay sedatie score, optreden van incidenten/complicatie en de diverse tijden (tijdstip start PSA, tijdstip start ingreep, eindtijd ingreep, tijdstip laatste gift PSA medicatie, tijdstip patiënt volledig herstelt van PSA, tijdstip ontslag patiënt).


    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    After inclusion of 6o patients in this study.
    Nadat er 60 patienten in deze studie zijn geincludeerd.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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