Effectiveness of Hypnoanalgesia for Dermatological Surgery in Children: Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia
- Sponsor
- Complejo Hospitalario de Toledo
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Total dose of propofol in mg/kg
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This randomized clinical trial will evaluate the effect of hypnosedation on the need of sedation and analgesia in a pediatric population undergoing dermatological surgery, both during the procedure, and 24 hours after surgery. In addition, a secondary objetive is to evaluate the effect by specific age groups.
Detailed Description
In this clinical trial, pediatric patients scheduled for removal of benign skin lesions in a single center willbe randomised to receive hypnosis (intervention group) or attention-distracting techniques (control group). Endpoints will be the sedative dose (propofol) during surgery, and the need for analgesia (paracetamol and others) immediately after surgery (recovery) and after 24 hours. Randomization will be systematic in blocks depending on the day the surgery is programmed. Hypnosis will be delivered by an experienced anesthesist trained in the technique. Patients and families will be informed of the special treatment during surgery, but will be unaware of whether the patients are experiencing distraction or hypnosis techniques. Distraction is already a useful technique, and it is expected that patients will be satisfied with the procedure; however, the hypothesis to be tested is that hypnosis reduces the need for sedation and analgesia compared to distraction techniques, as well as improves satisfaction.
Investigators
JUANA MARIA PELAEZ PEREZ
Anesthesiologist
Complejo Hospitalario de Toledo
Eligibility Criteria
Inclusion Criteria
- •A class I or II of anaesthetic risk according to the American Society of Anesthesiologists,
- •to be in a percentile between P3 and P97 in weight and height,
- •without known drug allergies, and
- •having fasted 6 hours for solids and 2 hours for water.
Exclusion Criteria
- •Children with diagnosed mental retardation or attention deficit,
- •behavioural disorders,
- •previous treatment with hypnosis,
- •history of neurological pathology or psychomotor retardation,
- •previous pain-related pathology,
- •obstructive sleep apnoea syndrome (OSAS)
Outcomes
Primary Outcomes
Total dose of propofol in mg/kg
Time Frame: During surgery (Intra-operative)
Measured in mg/kg weight
Total dose of propofol in mg
Time Frame: During surgery (Intra-operative)
Measured in total mg
Additional need for opioids during surgery
Time Frame: During surgery (Intra-operative)
Yes/no
Secondary Outcomes
- Pain intensity in older children after 24 hours(24 hours after discharge)
- Analgesic need(24 hours after discharge)
- Pain intensity in younger children after 24 hours(24 hours after discharge)
- Pain intensity in younger children post-operative(Immediately post-operative while on recovery unit)
- Pain intensity in older children post-operative(Immediately post-operative while on recovery unit)
- Analgesic needs(24 hours after discharge)