Children's mood/anxiety, pain, nausea and behavioral changes afterpremedication with Clonidine versus Midazolam in Ear Nose Throat day surgery.
- Conditions
- Preanesthetic Medication at ear-nose-throat surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-005215-42-SE
- Lead Sponsor
- Department of Anesthesiology and Intensive Care Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ear-Nose and Throat day surgery
Children 2-7 years of age
ASA (American Society of Anaesthesiologists Score) I-II
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Children not taken Preanesthetic Medication
Acute surgery
Children or guardians not speaking or understanding Swedish
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess children's behavioral changes after premedication with Clonidine versus Midazolam using PHBQ (Post Hospital Behavior Questionnaire);Secondary Objective: To assess children's mood/anxiety, pain and nausea, with different questionnaires and scales, after premedication with Clonidine versus Midazolam, and what impact on children’s behaviours they give;Primary end point(s): Assessment by PHBQ (Post Hospital Behavior Questionnaire) ;Timepoint(s) of evaluation of this end point: One week after surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Assessment with:<br>BTS (Childerns paitings at hospital)<br>m-YPAS (The modified Yale Preoperative Anxiety Scale)<br>FAS (Facial Affektive Scale)<br>FLACC (Face Legs Activity, Cry and Consolability scale).<br>FPS-R Face Pain Scale-Revised<br>PHBQ (Post Hospital Behavior Questionnaire) ;Timepoint(s) of evaluation of this end point: At the postsurgey ward<br>Before discharge from hospital<br>One month after surgery<br>Six month after surgery