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

IUD Insertion Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02522130
• Other study ID #: ob/gyn4
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2015
• Last updated: June 21, 2016
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Al Hayat National Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

Drug:
• Lidocaine
intracervical injection
• oral misoprostol
oral treatment
• naproxen
oral treatment

Other:
• placebo
oral treatment

Locations

Country	Name	City	State
Egypt	Menoufia University	Shebin Elkom
Saudi Arabia	Alhayah national hospital	Abha

Sponsors (2)

Lead Sponsor	Collaborator
Al Hayat National Hospital	Menoufia University

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes	Yes