Hypnoanalgesia for Dermatological Surgery in Children

Not Applicable

Completed

• Conditions: Anesthesia

• Registration Number: NCT04707014
• Lead Sponsor: Complejo Hospitalario de Toledo

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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-04-15
• Study Completion: 2018-04-30
• Study First Submitted: 2020-09-17
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-10
• Last Update Submitted: 2021-01-10
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Additional need for opioids during surgery	During surgery (Intra-operative)	Yes/no

Secondary Outcome Measures

Name	Time	Method
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
Analgesic need	24 hours after discharge	Recorded by a blinded nurse at reanimation unit as yes/no
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
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
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
Analgesic needs	24 hours after discharge	Recorded by a blinded nurse by telephone call as yes/no

Trial Locations

Locations (1)

Complejo Hospitalario Toledo; 🇪🇸 Toledo, Spain