Different Analgesics Prior to IUD Insertion: Is There Any Evidence?
Overview
- Phase
- Not Applicable
- Intervention
- Lidocaine
- Conditions
- IUD Insertion Complication
- Sponsor
- Al Hayat National Hospital
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
- Last Updated
- 9 years ago
Overview
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.
Investigators
mohamed maher
assistant professor
Al Hayat National Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients are considered eligible if:
- •they are alert oriented and co-operative to response to the visual analogue scale (VAS).
- •They will sign the informed consent to participate in the clinical trial before entering the study.
- •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:
- •A lidocaine allergy
- •Copper allergy
- •Current cervicitis
- •Pelvic inflammatory disease (PID) within 3 months
- •Uterine anomalies
- •Pain medication within 6 hours before insertion
- •Misoprostol administration within 24 hour before insertion
- •History of cervical surgery and contraindication to study medications.
Arms & Interventions
lidocaine group
Group A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion,
Intervention: Lidocaine
misoprostol group
Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion
Intervention: oral misoprostol
non steroid group
Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion
Intervention: naproxen
placebo group
group D will receive placebo tablets.
Intervention: placebo
Outcomes
Primary Outcomes
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
Time Frame: 15 minutes
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.