Analysis of pain after intramuscular injection of penicillin with larger gauge needles and local anesthetic versus traditional needle without anesthetic in patients with syphilis.

Phase 1

• Conditions: Pain due to intramuscular injection in syphilis.; MedDRA version: 17.1Level: PTClassification code 10062120Term: SyphilisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2014-003969-24-ES
• Lead Sponsor: Vicente Estrada Pérez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-10
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Support diagnosis of syphilis by serology (syphilis IgG + / + VDRL / TPHA + RPR + with) in the presence or absence of symptoms or clinical signs.
Need for treatment with intramuscular penicillin 2400000 U.
Acceptance to participate in the study after signing the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

Diagnosis of neurosyphilis associated with possible impairment of sensory perception of pain after administration of the drug.
Cognitive impairment who are unable or have difficulty understanding and evaluating the degree of pain on the visual analogue scale (VAS).
Background hipersensibililidad to beta-lactams.
Known hypersensitivity to lidocaine.
Confinement in prison.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Analyze if administration of penicillin in patients with syphilis with 19G needle, with or without lidocaine is associated with a reduction in pain compared to intramuscular administration with a 21G needle with or without lidocaine in the intramuscular injection.;Secondary Objective: To analyze the evolution of pain after administration of intramuscular penicillin in patients with syphilis at 6 and 24 h after injection with a 19 G needle with or without lidocaine versus injection administered with a 21 G needle with or without lidocaine.;Primary end point(s): Pain evolution after administration of intramuscular penicillin.;Timepoint(s) of evaluation of this end point: Baseline, 6 and 24 hours post-injection.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Demographic: Age, sex, etnic orign. <br>Anthropometric: Weight, height, BMI, circumference arm and thigh. <br>Pathological: HIV Infection; RPR value at the time of the inclusion in the study and 6 months later; clinical stage of syphilis (primary, secondary, latent). <br>Ischemic lesions, neurological deficits due to ischemic compromise of the sciatic nerve; paresis and paralysis corresponding to the injection member. <br>Discoloration and loss of function of the member to administration area. <br>Local irritant reaction.;Timepoint(s) of evaluation of this end point: Baseline, 6 and 24 hours post-injection.