Pain Prevention During Propofol Infusion in Pediatric: Hypnoanalgesia of the Hand Versus Lidocaine.

NCT03453723 | Completed Phase 4

• 2 other identifiers: RC31/17/00412017-002630-22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The simplicity of the implementation and the effectiveness of hypno-analgesia (via the magic glove technique) has already been proven in some research work, during the installation of peripheral venous route. An unpublished preliminary study has shown that this method appears to be the most effective in preventing pain during pediatric propofol injection. The purpose is to compare the effectiveness of hypno-analgesia of the hand by the "magic glove technique" to lidocaine used in an extemporaneous mixture in the prevention of pain with injection of propofol during intravenous induction in children aged 7 to 14 years

Conditions

Pain

Keywords

hypnoanalgesia; lidocaine; propofol; children

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Score: Cameron Type Scale

  The reactions of the child from the beginning of the injection are filmed by an outside observer. At the end of the 3 mg / kg, the observation is stopped. From a distance, a member of the Children's Hospital Pain Unit will blindly display, by viewing child-centered videos, a pain score, according to Cameron's score \[0 = No pain ( no reaction); 1 = slight pain (grimace); 2 = Moderate pain (grimaces + cries / moans); 3 = severe pain (crying / crying + hand removal).\]. A score greater than or equal to two represents a significant pain at induction.

  Day 1

Secondary Outcomes (1)

• Satisfaction assessment

  Day 1

Study Arms (2)

magic glove hypnosis

EXPERIMENTAL

Magic glove hypnosis technique use before propofol infusion

Procedure: Magic glove hypnosis technique

lidocaine

ACTIVE COMPARATOR

extemporaneous mixture with lidocaine for propofol infusion

Drug: lidocaine

Interventions

Magic glove hypnosis technique PROCEDURE

Realization of the magic glove hypnosis technique by an expert physician trained in hypnosis, according to a classic discourse before : intravenous infusion with 1% propofol (3 mg/kg with 600 ml / h electric syringe pump). Use and dose in accordance with the SPC.

magic glove hypnosis

lidocaine DRUG

intravenous infusion with an extemporaneous mixture of 18 volumes 1% propofol (180mg) for 2 volumes of 1% lidocaine (2ml) with 600 ml / h electric syringe pump. Use and dose in accordance with the SPC.

lidocaine

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children from 7 to 14 years old.
• Admitted for programmed or ambulatory surgery under general anesthesia.
• ASA I to II. (ASA1: Normal patient or ASA 2: Patient with moderate systemic abnormality).

You may not qualify if:

• Children under 7, over 14
• In regulated girls, presence of a pregnancy
• ASA III, IV
• Contraindication to propofol (known hypersensitivity to propofol or to one of its constituents)
• Contraindications to lidocaine (known hypersensitivity to lidocaine hydrochloride, amide bonded local anesthetics or to any of the excipients, patients with recurrent porphyria)
• Contraindications to nitrous oxide
• Patient whose clinical condition requires titration of propofol during induction, for good hemodynamic tolerance.
• Refusal by the child or the parents of intravenous induction.
• Psychological distress (agitation, mental deficiencies, communication disorders, deafness problems).
• Analgesic or sedative treatment within 24 hours before induction.
• Locoregional or perimedullary anesthesia before anesthetic induction.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital des enfants - Pôle Anesthésie-Réanimation.

Toulouse, 31059, France

Location

Related Publications (6)

• Cameron E, Johnston G, Crofts S, Morton NS. The minimum effective dose of lignocaine to prevent injection pain due to propofol in children. Anaesthesia. 1992 Jul;47(7):604-6. doi: 10.1111/j.1365-2044.1992.tb02335.x.

  PMID: 1626674 BACKGROUND

• Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.

  PMID: 21406529 BACKGROUND

• Nishimoto R, Kashio M, Tominaga M. Propofol-induced pain sensation involves multiple mechanisms in sensory neurons. Pflugers Arch. 2015 Sep;467(9):2011-20. doi: 10.1007/s00424-014-1620-1. Epub 2014 Oct 10.

  PMID: 25301522 BACKGROUND

• Depue K, Christopher NC, Raed M, Forbes ML, Besunder J, Reed MD. Efficacy of intravenous lidocaine to reduce pain and distress associated with propofol infusion in pediatric patients during procedural sedation. Pediatr Emerg Care. 2013 Jan;29(1):13-6. doi: 10.1097/PEC.0b013e31827b227e.

  PMID: 23283255 BACKGROUND

• Kuttner L. Pediatric hypnosis: pre-, peri-, and post-anesthesia. Paediatr Anaesth. 2012 Jun;22(6):573-7. doi: 10.1111/j.1460-9592.2012.03860.x.

  PMID: 22594409 BACKGROUND

• Polomeni MM, Huguet T, Mariotti M, Larcher C, Delort F, Minville V, Kern D. Avoiding pain during propofol injection in pediatric anesthesia: Hypnoanalgesia of the hand versus intravenous lidocaine. Paediatr Anaesth. 2024 Aug;34(8):742-749. doi: 10.1111/pan.14909. Epub 2024 May 2.

  PMID: 38693886 RESULT

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marie-Madeleine Polomeni, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: March 5, 2018
• Study Start: April 18, 2018
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: November 28, 2025

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)