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

Not Applicable

• Conditions: IUD Insertion Complication
• Interventions: Drug: oral misoprostol; Other: placebo; Drug: naproxen; Drug: Lidocaine

• Registration Number: NCT02522130
• Lead Sponsor: Al Hayat National Hospital

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol group	oral misoprostol	Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion
placebo group	placebo	group D will receive placebo tablets.
non steroid group	naproxen	Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion
lidocaine group	Lidocaine	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,

Primary Outcome Measures

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

Trial Locations

Locations (2)

Alhayah national hospital; 🇸🇦 Abha, Saudi Arabia

Menoufia University; 🇪🇬 Shebin Elkom, Egypt