EMLA Cream in Hysteroscopy Practice

Ain Shams Maternity Hospital

Status and phase: Unknown; Phase 2

Conditions: Anesthetics, Local

Treatments: Other: Placebo; Drug: EMLA

Study type: Interventional

Funder types: Other

Identifiers

NCT02640183

EMLA-Hsc

Details and patient eligibility

About

The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.

Enrollment: 184 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
5. Absence of sedative use 24 h before admission

Exclusion criteria

1. Hypersensitivity or allergy to anesthetics
2. refusal of the patient
3. Patients under age 18 and pregnant.
4. Patients on anti-arrhythmic drugs due to possibility of drug interaction.
5. Unbearable pain that involves other analgesic measures.
6. Allergic reactions to topical anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups, including a placebo group

Group A (EMLA)

Experimental group

Description:

3 mL EMLA® cream 5% will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

Treatment:

Drug: EMLA

Group B (Placebo)

Placebo Comparator group

Description:

3 mL of ultrasonic gel will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

Treatment:

Other: Placebo