Pain relief following Mirena Intrauterine Device (IUD) insertion: vaginal Diazepam vs placebo

Analgesia following Mirena IUD insertion, a randomised controlled trial: vaginal Diazepam vs placebo.

Status

Suspended

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001101875

Enrollment

Registered

2021-08-18

Start date

2022-07-21

Completion date

2023-01-05

Last updated

2023-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Levonorgestral-releasing intrauterine devices (LNG-IUS), such as the Mirena (Bayer), are being increasingly prescribed in Australia. Despite their proven efficacy in contraception, heavy menstrual bleeding and pelvic pain, overall population usage remains low. One of the contributing factors to this is thought to be fear around pain with and following IUD insertion. 59% of nulliparous women reported moderate to severe pain in the first 24 hours following LNG- IUD insertion, reducing to 31% from 24-72 hours. Vaginal administration of diazepam has been proposed as a treatment for pelvic floor muscle spasm and is recommended for this indication by the Pelvic Pain Foundation of Australia. Diazepam acts as a muscle relaxant and vaginal route of administration prolongs the half-life while allowing local administration. Oral preparations are currently being evaluated (clinicaltrials.gov), however, to our knowledge, no data exists on the impact of vaginal Diazepam administration following IUD insertion. Our aim is to evaluate the impact of a dose of vaginal diazepam following insertion of the Mirena IUD in an outpatient setting on pelvic pain and cramping. We hypothesise that patients will experience a reduction in post-insertion pain compared to placebo.

Interventions

Vaginal Diazepam following Mirena IUD Once only insertion of 10mg vaginal diazepam pessary by attending clinician immediately following Levonorgestrel Intrauterine Device (LNG-IUD) placement in an outpatient setting. The vaginal diazepam will be administered once only, by the clinician performing the procedure.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Premenopausal Nulliparous or multiparous Availability of carer to drive patient home from appointment Access to a computer and email account for completion of questionnaires Written English language proficiency to provide consent and complete questionnaires

Exclusion criteria

Allergy or contraindication to diazepam or pessary components Contraindication to outpatient insertion of IUD Postnatal <6/52 Breastfeeding

Outcome results