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

Different Analgesics Prior to IUD Insertion: Is There Any Evidence?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522130
Enrollment
200
Registered
2015-08-13
Start date
2015-07-31
Completion date
2016-12-31
Last updated
2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Insertion Complication

Brief summary

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

Detailed description

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.

Interventions

DRUGLidocaine

intracervical injection

DRUGoral misoprostol

oral treatment

DRUGnaproxen

oral treatment

OTHERplacebo

oral treatment

Sponsors

Menoufia University
CollaboratorOTHER
Al Hayat National Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

Egypt, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026