E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
We are investigating whether giving a child the drug clonidine during their anaesthetic may reduce behaviour changes after their discharge from hospital. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061422 |
E.1.2 | Term | Abnormal behaviour |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
The objective of this pilot study is to establish feasibility for a full study supported by the National Institute for Health Research Research for Patient Benefit program.
Our ultimate research question is:
Can we reduce the incidence of postoperative negative behaviour changes by giving the drug clonidine to children who are very upset during induction of anaesthesia (going to sleep)? |
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E.2.2 | Secondary objectives of the trial |
As a pilot study to establish feasibility, we wish to:
- assess recruitment rates - assess follow up rates - assess patient and parent acceptability - test our measurement tools (are they appropriate? Do they need to be refined?) - generate data for power analysis and determination of sample size. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age - two to 10 years inclusive.
Healthy - American Society of Anesthesiology (ASA) score 1 or 2 (indicating the absence of functional limitation due to illness)
Listed for elective extraction of teeth under general anaesthesia at the Bristol Dental Hospital
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E.4 | Principal exclusion criteria |
ASA grade 3 or above (indicating a child with significant co-morbidities which limit physical function)
Inability of the parents to understand the study or consent process (a good understanding of English is critical for the telephone interview)
Pre-operative anxiety requiring sedative premedication
A confirmed diagnosis of a behaviour disorder
A traumatic event within the last three months, for example parents divorce or moving house
Known allergy or insensitivity to clonidine |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of new postoperative negative behaviour changes identified by the Post hospitalisation behaviour questionnaire. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluated at 24 hours and seven days following general anaesthesia. |
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E.5.2 | Secondary end point(s) |
1. Degree of agitation during recovery from anaesthesia (PAED score and Watcha score) 2. Time in recovery 3. Time before hospital discharge 4. Post operative pain score 5. Days of school missed following procedure 6. Days of parental work missed following procedure
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Within 30 minutes of waking from anaesthesia 2. Within one hour of waking from anaesthesia 3. Within two hours of waking from anaesthesia 3. within two hours of waking from anaesthesia 5. Seven days following anaesthesia 6. Seven days following anaesthesia |
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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 | No |
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 | No |
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 |
Pilot study to assess feasibility |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
There will be 2 doses of active drug |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |