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

Randomized clinical trial to analysis of pain after administration intramuscular benzathine penicillin needle gauge and length greater local anesthetic or not, in the administration with a traditional intramuscular needle with or without local anesthetic in patients with syphilis. Dolben Study . - Dolben Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003969-24-ES

Enrollment

104

Registered

2014-12-10

Start date

2014-09-18

Completion date

Unknown

Last updated

2016-06-13

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

Conditions

Pain due to intramuscular injection in syphilis. MedDRA version: 17.1 Level: PT Classification code 10062120 Term: Syphilis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: BENZYLPENICILLIN SODIUM Product Code: SUB13038MIG Pharmaceutical Form: Solution for injection INN or Proposed INN: BENZYLPENICILLIN SODIUM CAS Number: 69-57-8 Current Sponsor code: PENIC

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary end point(s): Demographic: Age, sex, etnic orign. Anthropometric: Weight, height, BMI, circumference arm and thigh. 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). Ischemic lesions, neurological deficits due to ischemic compromise of the sciatic nerve; paresis and paralysis corresponding to the injection member. Discoloration and loss of function of the member to administration area. Local irritant reaction.;Timepoint(s) of evaluation of this end point: Baseline, 6 and 24 hours post-injection.	—

Measure

Time frame

Secondary end point(s): Demographic: Age, sex, etnic orign. Anthropometric: Weight, height, BMI, circumference arm and thigh. 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). Ischemic lesions, neurological deficits due to ischemic compromise of the sciatic nerve; paresis and paralysis corresponding to the injection member. Discoloration and loss of function of the member to administration area. Local irritant reaction.;Timepoint(s) of evaluation of this end point: Baseline, 6 and 24 hours post-injection.

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Countries

Spain

Contacts

Public ContactUNIDAD DE ENFERMEDADES INFECCIOSAS

VICENTE ESTRADA PÉREZ

vicente.estrada@salud.madrid.org349133030002774

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026