Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice (HISTEROS-07)

Consorci Sanitari de Terrassa

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Other: gel application for the transmission of ultrasound; Drug: lidocaine-prilocaine cream

Study type: Interventional

Funder types: Other

Identifiers

NCT01094015

HISTEROS-07

Details and patient eligibility

About

The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.

Enrollment: 92 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• patients that he must perform a diagnostic hysteroscopy
• acceptance to participate in the study signed informed consent

Exclusion Criteria prerandomization:

• hypersensitivity or allergy to anesthetics
• refusal of the patient
• patients under age 18 and pregnant

Exclusion Criteria postrandomization:

• dropout
• unbearable pain that involves other analgesic measures
• allergic reactions to topical anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups, including a placebo group

Lidocaine-Prilocaine cream

Active Comparator group

Treatment:

Drug: lidocaine-prilocaine cream

placebo

Placebo Comparator group

Treatment:

Other: gel application for the transmission of ultrasound