Clinical trial NCT04707014: Hypnoanalgesia for Dermatological Surgery in Children
Official title: Effectiveness of Hypnoanalgesia for Dermatological Surgery in Children: Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: analgesia
anxiety
pain
paediatric surgery
dermatology
Hypnosis
Nervous System Diseases Central
Hypnotics and Sedatives
Nervous System Depressants
Physiological Effects of Drugs
Lead sponsor: Complejo Hospitalario de Toledo
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total dose of propofol in mg/kg
timeFrame: During surgery (Intra-operative)
measure: Total dose of propofol in mg
timeFrame: During surgery (Intra-operative)
measure: Additional need for opioids during surgery
timeFrame: During surgery (Intra-operative)
Secondary outcomes:
measure: Pain intensity in older children post-operative
timeFrame: Immediately post-operative while on recovery unit
measure: Pain intensity in younger children post-operative
timeFrame: Immediately post-operative while on recovery unit
measure: Pain intensity in older children after 24 hours
timeFrame: 24 hours after discharge
measure: Pain intensity in younger children after 24 hours
timeFrame: 24 hours after discharge
measure: Analgesic need
timeFrame: 24 hours after discharge
measure: Analgesic needs
timeFrame: 24 hours after discharge
Other outcomes:
measure: Degree of satisfaction with the procedure
timeFrame: 24 hours after discharge
Locations:
city: Toledo
country: Spain
facility: Complejo Hospitalario Toledo
Study officials:
affiliation: Complejo Hospitalario Toledo
name: Juana Maria PELAEZ PEREZ, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedrichsdorf SJ, Kohen DP. Integration of hypnosis into pediatric palliative care. Ann Palliat Med. 2018 Jan;7(1):136-150. doi: 10.21037/apm.2017.05.02. Epub 2017 Jun 27.
citation: Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.
citation: Brown ML, Rojas E, Gouda S. A Mind-Body Approach to Pediatric Pain Management. Children (Basel). 2017 Jun 20;4(6):50. doi: 10.3390/children4060050.
citation: Friedrichsdorf SJ, Goubert L. Pediatric pain treatment and prevention for hospitalized children. Pain Rep. 2019 Dec 19;5(1):e804. doi: 10.1097/PR9.0000000000000804. eCollection 2020 Jan-Feb.