The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population (NCT03918798) | Clinical Trial Compass
CompletedPhase 2
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Italy164 participantsStarted 2019-02-14
Plain-language summary
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric population subjected to peripheral nerve block due to Inguinal hernia repair or Flat foot surgery. The present Protocol is part of an extensive Pediatric Investigational Plan (PIP) in the contest of the marketing authorization application of chloroprocaine use for perineural block. The PDCO has adopted a positive opinion.
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
✓. Male and female paediatric patients from birth to \<18 years scheduled for:
✓. Normally active and otherwise judged to be in good health on the basis of medical history, physical examination, with normal lean body mass (BMI18,5 - 24,9 Kg/m2 inclusive) and normal body development (normal weight and height according to local paediatric Height and Weight Chart);
✓. ASA I and ASA II patients;
✓. Written informed consent provided by parents/tutor, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements;
✓. Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor;
✓. Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.
Exclusion criteria
✕. ASA \> II patients;
✕. Preexistent infection at injection site;
✕. Use of opioids, antidepressants, anticonvulsant, sulfonamide, vasopressors, ergot-type oxytocic drug and mixtures of local anaesthetics, antiarrhythmic drug class III, such as amiodarone, strong inhibitors of CYP1A2, such as fluvoxamine and enoxacin;
✕. Use of medication(s) known to interfere with the extent of regional blocks for 2 weeks before the start of the study;
What they're measuring
1
Overall proportion of patients, in each of the two dosage level groups, not requiring rescue anesthesia during surgery.
✕. Sensitivity among the study medication active ingredient, the members of the PABA esters group and amides-type local anesthetic group;
✕. Clinical history of allergy, hypersensitivity or intolerance to the study medication or other medications used during surgery;
✕. Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating (the pregnancy test will be performed to all fertile subset);