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

November 21, 2025 updated by: University Hospital, Toulouse

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 An unpublished preliminary study has shown that this method appears to be the most effective in preventing pain during pediatric propofol injection.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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Propofol is a hypnotic of choice, because of its speed of action, its dose-effect relationship (allowing titrated inductions), its anti-emetic effect, as well as its delay and its short duration of action. Among its side effects, the pain during its injection occupies a significant part in pediatrics (60% in adults, up to 85% in children).

It is most often described as an unpleasant sensation, discomfort or even a burn at the point of puncture, going up along the path of the vein and can extend to the whole arm. The mechanism of this pain is still poorly understood at this time. Several mechanisms have been mentioned such as activation of the bradykinin cascade, a direct stimulation of the free nociceptive venous nerve endings.A meta-analysis concludes in adults that the two most effective techniques are a puncture site on the ulnar vein and a pretreatment of the vein by Lidocaine. In children, the anatomical differences, the notion of protection of the venous capital from the first vascular approach, whatever the prognosis of the patient and the competence of the operator will influence the choice of the material, the choice of the site and the puncture technique. Several pediatric studies have attempted to reduce this injection pain by other techniques. A panel of products has been tested with different drug orientations or not. The suggestion centered on analgesia of the hand is a powerful technique, adapted to acute pain. The pain sensation will thus be partially or completely replaced by a sensation of a different nature, thus attenuating the nociceptive process. This technique has not been studied during injection with propofol.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Hôpital des enfants - Pôle Anesthésie-Réanimation.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • Parents or legal guardians who have signed informed consent to the inclusion visit.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: magic glove hypnosis
Magic glove hypnosis technique use before propofol infusion
Procedure: Magic glove hypnosis technique
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.
Active Comparator: lidocaine
extemporaneous mixture with lidocaine for propofol infusion
Drug: lidocaine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Score: Cameron Type Scale
Time Frame: Day 1

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction assessment
Time Frame: Day 1
Evaluation of the satisfaction as soon as the child is able to leave the post interventional surveillance room (sspi) by an analog evaluation scale of the degree of satisfaction. A score ≤ 7 expressing dissatisfaction on his part, the reasons for this possible discontent will then be requested. Then, we will ask him, in case he should be asleep, if he wants us to proceed in the same way.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Marie-Madeleine Polomeni, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Actual)

June 19, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Estimated)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/17/0041
  • 2017-002630-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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