Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion (GTN-IUD)

Assiut University

Status and phase: Completed; Phase 4

Conditions: IUD Insertion

Treatments: Drug: placebo cream; Drug: lidocaine cream; Drug: glyceryl trinitrate cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02708251

GTN

Details and patient eligibility

About

The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive method that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. Women can experience high levels of pain when the IUD is placed inside the uterus, and fear of this pain could be a reason that women decide not to use this method.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women not taken analgesics or anxiolytics in the 24 hours prior insertion
2. Women not taken misoprostol prior to IUD insertion
3. No contraindication to or history of allergic reaction to lidocaine or NO donors.
4. Women who will accept to participate in the study

Exclusion criteria

1. Lidocaine allergy
2. History of migraine or chronic headache
3. Any contraindication to IUD placement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

glyceryl trinitrate cream

Experimental group

Description:

The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL glyceryl trinitrate cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.

Treatment:

Drug: glyceryl trinitrate cream

lidocaine cream

Experimental group

Description:

The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine. 1 mL lidocaine creamwill be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.

Treatment:

Drug: lidocaine cream

placebo cream

Placebo Comparator group

Description:

The clinician will perform a bimanual examination, place the speculum, and cleanse the cervix with Betadine.1 mL placebo cream will be placed on the cervix at the anterior lip and 1 mL in the cervix up to the level of the internal os using cotton swab.

Treatment:

Drug: placebo cream