Hypnoanalgesia for Dermatological Surgery in Children

Anesthesia Clinical Trial

Official title:

Effectiveness of Hypnoanalgesia for Dermatological Surgery in Children: Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707014
• Other study ID #: CHT00028
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2021
• Source: Complejo Hospitalario de Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 30, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Behavioral:
• Hypnosis
Rapid conversational hypnosis
• Attention-distracting techniques
i-pad with movies, games and music

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Toledo	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario de Toledo

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Brown ML, Rojas E, Gouda S. A Mind-Body Approach to Pediatric Pain Management. Children (Basel). 2017 Jun 20;4(6). pii: E50. doi: 10.3390/children4060050. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Degree of satisfaction with the procedure	Validated survey with score 1-10 administered at the time of discharge to children and their guardians.	24 hours after discharge
Primary	Total dose of propofol in mg/kg	Measured in mg/kg weight	During surgery (Intra-operative)
Primary	Total dose of propofol in mg	Measured in total mg	During surgery (Intra-operative)
Primary	Additional need for opioids during surgery	Yes/no	During surgery (Intra-operative)
Secondary	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	Immediately post-operative while on recovery unit
Secondary	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	Immediately post-operative while on recovery unit
Secondary	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	24 hours after discharge
Secondary	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	24 hours after discharge
Secondary	Analgesic need	Recorded by a blinded nurse at reanimation unit as yes/no	24 hours after discharge
Secondary	Analgesic needs	Recorded by a blinded nurse by telephone call as yes/no	24 hours after discharge