Anesthetics, Local
Conditions
Brief summary
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.
Interventions
DRUGEMLA
OTHERPlacebo
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain experienced during the procedure scored using a VAS. | Procedure | All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure. After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed. |
Outcome results
None listed