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    Summary
    EudraCT Number:2004-004394-28
    Sponsor's Protocol Code Number:04\Q0704\38
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-15
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2004-004394-28
    A.3Full title of the trial
    The use of local anasthesia for pain control in children undergoing dental general anaesthesia
    A.3.2Name or abbreviated title of the trial where available
    Pain control in children having a dental general anaesthesia
    A.4.1Sponsor's protocol code number04\Q0704\38
    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 SponsorGuy's & St Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Xylocaine 2% with 1:80000 adrenaline
    D.2.1.1.2Name of the Marketing Authorisation holderDentsply Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameXylocaine 2% with Adrenaline 1:80000
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPDental use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdrenaline bitartate for injection
    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 No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Patients requiring dental restorations of decayed teeth and dental extractions of teeth with dental abscesses.
    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
    To evaluate the effectiveness of pre-emptive analgesia for pain control in children undergoing a denal general anaesthesia (DGA)
    E.2.2Secondary objectives of the trial
    Assess the effectiveness and acceptability of intra-crestal analgesia as a method of pain control in children having dental restorations/extractions under DGA
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Children:

    AGED 5-12 YEARS
    ASA 1 and ASA 2
    Attending Guy's Hospital for dental treatment under DGA
    Treatment involving symmetrical extractions +/- restorative care
    E.4Principal exclusion criteria
    Patients with learning dental / mental disabilities.
    Patients at risk of infective endocarditis
    Patients who are immunocompromised
    Patients with acute infections
    E.5 End points
    E.5.1Primary end point(s)
    PATIENTS AND METHODS
    Patient selection
    1. Healthy children, ASA I and II, (those suitable for day case dental general anaesthetic) between 5-12 years of age, requiring symmetrical extractions +/- restorations under day-stay DGA.
    2. Those patient's with special needs (those at risk of endocarditis) will be excluded from the study.
    3. Those children who have learning disabilities, who would be unable of completing the questionnaires.

    Methods
    1. ICA, will be administered on one side of the patient's mouth only, by random assignment.
    2. Each subject will act as his/her own control using the half-mouth study design. The test side will receive ICA and the control side will not.

    PROCEDURE
    Pre-operatively
    1. The principle investigator (JJ) would carry out all the pre-operative assessments.
    2. An information sheet will be prepared for the parents/ carer and the child.
    3. Previous medical and dental history would be obtained, including details about previous GA/LA experience and complications associated with either.
    4. Pre-operative anxiety levels of the patients would be assessed using the Venham Picture Scale or Facial Image Scale.
    5. The anxiety levels of the parents would be measured by the Corah Anxiety Scale.
    6. Patient's pre-operative behaviour would be assessed using the Frankl Scale.
    7. Pre-operative waiting time of the patient on the day of the GA would be recorded.
    8. Patient's pre-operative blood pressure, heart rate and pulse would be measured.

    Intra-operatively
    1. Test side of ICA would be randomly chosen.
    2. Local anaesthetic (2% lignocaine + 1:80,000 adrenaline) would be administered intra crestally just prior to extractions. ICA would be administered adjacent to the teeth which would require restoration just prior to completion of the DGA. Maximum of one cartridge (2.2 ml) will be used for each patient. The same batch of drug will be used for all patients in the study.
    3. The time taken for extractions on each side of the mouth and the complexity of each extraction would also be measured using the degree of difficulty index (e.g. the root length of all the extracted teeth will be measured).
    4. The principle investigator would be blind to the side of ICA administration.

    Post-operatively
    1. The prinicple investigator (JJ) would carry out all post-operative assessments.
    2. On recovery from the DGA the patients would be asked to measure the level of pain on each side of their mouth using the Visual Analogue Scale.
    3. They would also be asked which side of the mouth they preferred, if they felt numbness, which side felt better/worse.
    4. Post-operative analgesia requirements for each patient would also be recorded.
    5. Patient's post-operative anxiety would also be recorded using the Venham Picture Test or Facial Image Scale.
    6. Blood pressure, heart rate and pulse would also be measured.
    7. The prinicple investigator (JJ) would also check the mouth for any evidence of self-induced injury before discharging the patient.
    8. The patients will be contacted by phone 24 and 48 hours post-operatively to assess their recovery.
    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 No
    E.6.4Safety No
    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 Yes
    E.6.13.1Other scope of the trial description
    ACCEPATBILITY TO CHILDREN
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3.1Comparator description
    UNANAESTHETISED CONTROL SIDE OF MOUTH
    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 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
    Last visit of the last subject
    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 months
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children (aged 5 - 12 years)
    Parents/Carers give consent for those children who are not able to understand issues of consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 30
    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)
    It is not anticipated that any futher treatment will be required.
    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 Decision2005-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-20
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