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Completed

NCT Number: NCT04707014

Hypnoanalgesia for Dermatological Surgery in Children

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.

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Key information

Conditions

Anesthesia Agnosia Anxiety Disorders Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario Toledo

Toledo, 45002, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A class I or II of anaesthetic risk according to the American Society of Anesthesiologists,
  • to be in a percentile between P3 and P97 in weight and height,
  • without known drug allergies, and
  • having fasted 6 hours for solids and 2 hours for water.

Exclusion criteria

  • Children with diagnosed mental retardation or attention deficit,
  • behavioural disorders,
  • previous treatment with hypnosis,
  • history of neurological pathology or psychomotor retardation,
  • previous pain-related pathology,
  • obstructive sleep apnoea syndrome (OSAS)

Treatment and study plan

hypnosis

Behavioral

Rapid conversational hypnosis

Other names: Hypnoanalgesia, Hypnosedation

Attention-distracting techniques

Behavioral

i-pad with movies, games and music

Primary outcomes

  1. Total dose of propofol in mg/kg

    Time frame: During surgery (Intra-operative)

    Measured in mg/kg weight

  2. Total dose of propofol in mg

    Time frame: During surgery (Intra-operative)

    Measured in total mg

  3. Additional need for opioids during surgery

    Time frame: During surgery (Intra-operative)

    Yes/no

Secondary outcomes

  1. Pain intensity in older children post-operative

    Time frame: 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

  2. Pain intensity in younger children post-operative

    Time frame: 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

  3. Pain intensity in older children after 24 hours

    Time frame: 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

  4. Pain intensity in younger children after 24 hours

    Time frame: 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

  5. Analgesic need

    Time frame: 24 hours after discharge

    Recorded by a blinded nurse at reanimation unit as yes/no

  6. Analgesic needs

    Time frame: 24 hours after discharge

    Recorded by a blinded nurse by telephone call as yes/no

Other outcomes

  1. Degree of satisfaction with the procedure

    Time frame: 24 hours after discharge

    Validated survey with score 1-10 administered at the time of discharge to children and their guardians.

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario de Toledo

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2021
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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