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    Summary
    EudraCT Number:2005-003287-28
    Sponsor's Protocol Code Number:lustgas 2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2005-08-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-003287-28
    A.3Full title of the trial
    Nitrous oxide for analgesia and sedation during procedural pain in children
    -Efficacy ina short and long perspective regarding joint injections
    A.4.1Sponsor's protocol code numberlustgas 2
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorQueen Silvia's Childrens hospital
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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 Information not present in EudraCT
    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 nameMedimix
    D.3.2Product code NO
    D.3.4Pharmaceutical form Inhalation gas
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namenitrous oxide/oxygen
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    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
    Juvenile Idiopathic Arthrithis (JIA)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective
    To test the primary hypothesis:

    1. PAIN:
    Patient will not grade his/her pain higher during joint injection (procedural pain), than before the procedure (base line of pain). This is measured by Coloured Analogue Scale (CAS) by the patient.

    2. TOTAL IMPRESSION:
    Patient state that they prefer Nitrous Oxide (50%N2O/50%O2) during a future joint injection, to receive adequate analgesia and sedation. This is measured by asking the patient immediately after the procedure and after one week, endpoint yes – no. Each patient will also grade his/her feelings before, during and after procedure by Facial Analogue Scale (FAS) immediately after the procedure and after one week.
    E.2.2Secondary objectives of the trial
    To test secondary hypothesis:

    1. TOTAL IMPRESSION:
    Nitrous Oxide (50%N2O/50%O2) is the method for receiving analgesia and sedation that the patient believes is the best during joint injections, according to those patients whom have tried other methods for receiving analgesia and sedation during joint injections.
    2. FASTING TIME: No increase of presence of nausea and vomiting for those patients that have two hours fasting time versus those patients that have four hours of fasting time.

    Patients who are subject to a second treatment with joint injections during the course of the study will be asked to test Guided Imagery for analgesia. Nitrous Oxide (50%N2O/50%O2) is then told by the patient to be better than Guided Imagery regarding analgesia, when we ask the patient immediatly after procedure and after one week.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. ASA 1 and ASA 2 patients with an acute phase of of JIA
    2. Age 5-18 years
    3. Written informed consent by patient and/or parent. The doctor have initially asked and informed about participation in the study if there are no contra-indications
    E.4Principal exclusion criteria
    1. More than 3 joints need intra articular cortisone injection
    2. Language difficulties
    3. Present infection
    4. Psychologically unstable patients (for example psychogical trauma, bad experience from war etc)
    5. Clinically significant heart/lung disease
    6. Pathological B12-status
    7. Affected CNS
    8. Porphyria
    E.5 End points
    E.5.1Primary end point(s)
    Primary variables:
    1. PAIN
    Patient will grade his/her pain before the procedure (baseline of pain) and during joint injection (preocedural pain), by Coloured Analogue Scale (CAS). Endpoints are from “no pain” – “worst pain ever experienced”

    2. TOTAL IMPRESSION
    Patients will be asked immediately after the procedure, and after one week if they prefer Nitrous Oxide (50%N2O/50%O2) during a future joint injection, to receive adequate analgesia and sedation (endpoint: yes – no). Each patient will also grade his/her feelings before, during and after procedure by Facial Analogue Scale (FAS) immediately after the procedure and after one week.

    Secondary variables:
    1. PREFERENCE
    Patients, whom have tried other methods for receiving analgesia and sedation during joint injections, will be asked immediately after the procedure, and after one week about their preferred method for receiving analgesia and sedation during joint injections.

    Patients who are subject to a second treatment with joint injections during the course of the study will be asked to test Guided Imagery for analgesia. Patients who agree to this treatment will be asked immediately after the procedure, and after one week about their preference for Nitrous Oxide (50%N2O/50%O2) or Guided Imagery as the method for receiving analgesia and sedation during joint injections.

    2. FASTING TIME
    Presence of nausea and vomiting for those patients that have two hours fasting time versus those patients that have four hours of fasting time will be measured by asking and observing the patient during procedure, and by asking the patient after one week.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Not appliable
    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 Decision2005-09-28
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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