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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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IUD Insertion Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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,

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

intracervical injection

misoprostol group

Group B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion

Group Type ACTIVE_COMPARATOR

oral misoprostol

Intervention Type DRUG

oral treatment

non steroid group

Group C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion

Group Type ACTIVE_COMPARATOR

naproxen

Intervention Type DRUG

oral treatment

placebo group

group D will receive placebo tablets.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

oral treatment

Interventions

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Lidocaine

intracervical injection

Intervention Type DRUG

oral misoprostol

oral treatment

Intervention Type DRUG

naproxen

oral treatment

Intervention Type DRUG

placebo

oral treatment

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes