Contraception, Intrauterine Device
Conditions
Keywords
Intrauterine device, lidocaine spray
Brief summary
Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.
Detailed description
Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in several steps during insertion such as applying tenaculum, applying uterine sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this contraceptive method. Previous researches reported mean pain score with using visual analog scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is used before IUD insertion procedure. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD. Lidocaine is introduced to use for pain relieving in medical procedures with advantages of rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic method that use in obstetrics and gynecology procedures and has favorable efficacy in reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD insertion. In this study, we investigate pain during IUD insertion using lidocaine spray compared with placebo.
Interventions
DRUGlidocaine spray
10% lidocaine spray 4 puffs
DRUGPlacebo
Sterile water 4 puffs
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Woman who required for Copper T IUD insertion * Body mass index 18.5 - 30 kg/m2 * Communicable with Thai language * New IUD user
Exclusion criteria
* Suspicion of pregnancy * Puerperal sepsis/Immediate post-septic abortion * Untreated abnormal uterine bleeding * Uterine anomaly/abnormal pathology distorting the uterine cavity * Current pelvic inflammatory disease * Untreated cervicitis/vaginitis * Wilson's disease * Copper allergy * known hypersensitivity to local anaesthetic * Analgesic or anxiolytic use within the last 24 h before the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale | Immediately after the procedure | Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects of 10% Lidocaine spray | 20 minutes after the procedure | Presence or absence of side effects |
Countries
Thailand
Outcome results
None listed