E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients requiring dental restorations of decayed teeth and dental extractions of teeth with dental abscesses. |
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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 evaluate the effectiveness of pre-emptive analgesia for pain control in children undergoing a denal general anaesthesia (DGA) |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal exclusion criteria |
Patients with learning dental / mental disabilities. Patients at risk of infective endocarditis Patients who are immunocompromised Patients with acute infections
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E.5 End points |
E.5.1 | Primary 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
ACCEPATBILITY TO CHILDREN |
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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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
UNANAESTHETISED CONTROL SIDE OF MOUTH |
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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 | Information not present in EudraCT |
E.8.7 | Trial 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
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Last visit of the last subject |
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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 | |
E.8.9.1 | In the Member State concerned days | |