Pain prevention during propofol infusion in pediatric: hypnoanalgesia of the hand versus lidocaine.

Pain prevention during propofol infusion in pediatric: hypnoanalgesia of the hand versus lidocaine. - PROPLIDHYPNO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002630-22-FR

Enrollment

100

Registered

2018-01-16

Start date

2018-01-18

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

surgery under general anaesthetic MedDRA version: 20.0 Level: PT Classification code 10054799 Term: Perioperative analgesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Propofol PANPHARMA Product Name: Propofol Pharmaceutical Form: Emulsion for injection Trade Name: CHLORHYDRATE DE LIDOCAINE Product Name: CHLORHYDRATE DE LIDOCAINE Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - aged 7 to 14, - ASA I and II, - Admitted for scheduled surgery under general anaesthetic Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - ASA III and IV - propofol contraindication - lidocaine contraindication - azote protoxyde contraindication - psychological distress

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacity of hypnoanalgesia of the hand in order to reduce propofol-induced pain in children compared to the administration of a lidocaine-propofol admixture;Secondary Objective: The secondary objectives of the trial is to evaluate the satisfaction of patient's anaesthetic, post surgery.;Primary end point(s): The primary end point is the pain intensity evaluated by the Cameron's score.;Timepoint(s) of evaluation of this end point: 15 minutes	—

Measure

Time frame

Main Objective: Evaluate the efficacity of hypnoanalgesia of the hand in order to reduce propofol-induced pain in children compared to the administration of a lidocaine-propofol admixture;Secondary Objective: The secondary objectives of the trial is to evaluate the satisfaction of patient's anaesthetic, post surgery.;Primary end point(s): The primary end point is the pain intensity evaluated by the Cameron's score.;Timepoint(s) of evaluation of this end point: 15 minutes

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary end point is the patient's satisfaction about anesthesia, evaluated by a modified Aldrete 3 score.;Timepoint(s) of evaluation of this end point: 8 hours	—

Countries

France

Contacts

Public ContactALGANS

University Hospital of Toulouse

algans.n@chu-toulouse.fr+330561777204

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026