Anesthesia
Conditions
Keywords
analgesia, anxiety, pain, paediatric surgery, dermatology, Hypnosis, Nervous System Diseases Central, Hypnotics and Sedatives, Nervous System Depressants, Physiological Effects of Drugs
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.
Interventions
BEHAVIORALHypnosis
Rapid conversational hypnosis
BEHAVIORALAttention-distracting techniques
i-pad with movies, games and music
Sponsors
Complejo Hospitalario de Toledo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Different investigators are assigned to each phase of the study, with one designated as responsible for recruitment (MQD), another for intervention and control (JMPP), and another for subsequent evaluation in the post-anaesthesia recovery unit (URPA) and at 24 hours (responsible nursing staff).
Intervention model description
Patients are randomly distributed to one of the following groups: Intervention group: Technique of rapid conversational hypnosis, with focus on therapeutic suggestion (guiding the patient into a hypnotic trance), adapted to child's cognitive development. Induction with hypnotic suggestion focuses and accompanies the child's body sensations and allows their active participation. After standard sedation, therapeutic suggestion is maintained throughout the surgery and in the post-hypnotic period before awakening. Control group: High-tech distraction technique (Apple®), passive and chosen by the child, either an animated video or his or her favourite music. After standard intravenous sedation, the child is taken to the operating theatre to watch his or her favourite video or music and this is maintained throughout the procedure.
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. A class I or II of anaesthetic risk according to the American Society of Anesthesiologists, 2. to be in a percentile between P3 and P97 in weight and height, 3. without known drug allergies, and 4. having fasted 6 hours for solids and 2 hours for water.
Exclusion criteria
1. Children with diagnosed mental retardation or attention deficit, 2. behavioural disorders, 3. previous treatment with hypnosis, 4. history of neurological pathology or psychomotor retardation, 5. previous pain-related pathology, 6. obstructive sleep apnoea syndrome (OSAS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Additional need for opioids during surgery | During surgery (Intra-operative) | Yes/no |
| Total dose of propofol in mg/kg | During surgery (Intra-operative) | Measured in mg/kg weight |
| Total dose of propofol in mg | During surgery (Intra-operative) | Measured in total mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity in older children after 24 hours | 24 hours after discharge | 0-10 visual analogue scale (VAS) administered over the phone by a blinded nurse, with higher values indicating higher levels of pain |
| Pain intensity in younger children after 24 hours | 24 hours after discharge | 0-10 Faces Pain Scale - Revised (FPS-r) administered over the phone by a blinded nurse, with higher values indicating higher levels of pain |
| Analgesic needs | 24 hours after discharge | Recorded by a blinded nurse by telephone call as yes/no |
| Analgesic need | 24 hours after discharge | Recorded by a blinded nurse at reanimation unit as yes/no |
| Pain intensity in older children post-operative | Immediately post-operative while on recovery unit | 0-10 visual analogue scale (VAS) administered by a blinded nurse, with higher values indicating higher levels of pain |
| Pain intensity in younger children post-operative | Immediately post-operative while on recovery unit | 0-10 Faces Pain Scale - Revised (FPS-r) administered by a blinded nurse, with higher values indicating higher levels of pain |
Other
| Measure | Time frame | Description |
|---|---|---|
| Degree of satisfaction with the procedure | 24 hours after discharge | Validated survey with score 1-10 administered at the time of discharge to children and their guardians. |
Countries
Spain
Outcome results
None listed