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

Al Hayat National Hospital

Status: Unknown

Conditions: IUD Insertion Complication

Treatments: Drug: oral misoprostol; Other: placebo; Drug: Lidocaine; Drug: naproxen

Study type: Interventional

Funder types: Other

Identifiers

NCT02522130

ob/gyn4

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

lidocaine group

Active Comparator group

Description:

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,

Treatment:

Drug: Lidocaine

misoprostol group

Active Comparator group

Description:

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

Treatment:

Drug: oral misoprostol

non steroid group

Active Comparator group

Description:

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

Treatment:

Drug: naproxen

placebo group

Placebo Comparator group

Description:

group D will receive placebo tablets.

Treatment:

Other: placebo