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Clinical Trials/EUCTR2014-003969-24-ES
EUCTR2014-003969-24-ES
Active, not recruiting
Phase 1

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

Vicente Estrada Pérez0 sites104 target enrollmentDecember 10, 2014
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ConditionsPain due to intramuscular injection in syphilis.MedDRA version: 17.1Level: PTClassification code 10062120Term: SyphilisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsLIDOCAINE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pain due to intramuscular injection in syphilis.
Sponsor
Vicente Estrada Pérez
Enrollment
104
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 10, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Vicente Estrada Pérez

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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