Hypnoanalgesia for Dermatological Surgery in Children

Complejo Hospitalario de Toledo28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Anesthesia

Interventions

HypnosisBEHAVIORAL

Rapid conversational hypnosis

Attention-distracting techniquesBEHAVIORAL

i-pad with movies, games and music

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

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)

Locations (1)

Complejo Hospitalario Toledo

Toledo, Spain

Outcomes

Primary Outcomes

Total dose of propofol in mg/kg

Measured in mg/kg weight

Time frame: During surgery (Intra-operative)

Total dose of propofol in mg

Measured in total mg

Time frame: During surgery (Intra-operative)

Additional need for opioids during surgery

Yes/no

Time frame: During surgery (Intra-operative)

Secondary Outcomes

Pain intensity in older children post-operative

0-10 visual analogue scale (VAS) administered by a blinded nurse, with higher values indicating higher levels of pain

Time frame: Immediately post-operative while on recovery unit

Pain intensity in younger children post-operative

0-10 Faces Pain Scale - Revised (FPS-r) administered by a blinded nurse, with higher values indicating higher levels of pain

Time frame: Immediately post-operative while on recovery unit

Pain intensity in older children after 24 hours

0-10 visual analogue scale (VAS) administered over the phone by a blinded nurse, with higher values indicating higher levels of pain

Time frame: 24 hours after discharge

Pain intensity in younger children after 24 hours

0-10 Faces Pain Scale - Revised (FPS-r) administered over the phone by a blinded nurse, with higher values indicating higher levels of pain

Time frame: 24 hours after discharge

Analgesic need

Data from ClinicalTrials.gov

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