Behaviour MedDRA version: 16.0 Level: PT Classification code 10061422 Term: Abnormal behaviour System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Catapres
Product Name: Catapres
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Clonidine hydrochloride
CAS Number: 4205-90-7
Other descriptive name: N-(2,6-dichlorophenyl
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 45 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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)?;Secondary Objective: 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.;Primary end point(s): The number of new postoperative negative behaviour changes identified by the Post hospitalisation behaviour questionnaire. ;Timepoint(s) of evaluation of this end point: Evaluated at 24 hours and seven days following general anaesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Countries
United Kingdom
Outcome results
None listed