Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?

Al Hayat National Hospital200 enrolled

Overview

Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role

A randomized clinical controlled trial of women undergoing IUD insertion. Participants in the study groups will be randomly assigned by labeled opaque envelopes to either1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt), misoprostol (Sigma, Egypt), naproxen (Naprosyn, Syntax, Egypt) or placebo tablets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

IUD Insertion Complication

Interventions

LidocaineDRUG

intracervical injection

oral misoprostolDRUG

oral treatment

naproxenDRUG

oral treatment

placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Patients are considered eligible if: 1. they are alert oriented and co-operative to response to the visual analogue scale (VAS). 2. They will sign the informed consent to participate in the clinical trial before entering the study. 3. Willingness to be randomized and complete study questionnaires. Exclusion Criteria: Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as: 1. A lidocaine allergy 2. Copper allergy 3. Current cervicitis 4. Pelvic inflammatory disease (PID) within 3 months 5. Uterine anomalies 6. Pain medication within 6 hours before insertion 7. Misoprostol administration within 24 hour before insertion 8. History of cervical surgery and contraindication to study medications.

Locations (2)

Menoufia University

Shebin Elkom, Egypt

RECRUITING

Alhayah national hospital

Abhā, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.

A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable). The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement.

Time frame: 15 minutes

Data from ClinicalTrials.gov

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