Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement
Recruitment status was Recruiting
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pain Control for Intrauterine Device Placement: A Randomized, Double Blind Control Trial of Ketorolac Prior to Intrauterine Device Placement.|
- VAS (Visual Analogue Scale) measurement of pain [ Time Frame: Anticipated pain, prior to study drug administration, Pain with study drug administration, Speculum placement, Tenaculum placement, Uterine sounding, With intrauterine device placement, 5 min after IUD placement,15 min after IUD placement ] [ Designated as safety issue: No ]The patient will mark their pain on a 100mm visual analogue scale at 8 different time points as listed above. In addition, at the end of the study they will be offered acetaminophen prior to leaving the office. Their charts will also be assessed to determine if they called in for any additional stronger pain medications within the first 24 hours.
- Post-insertion patient questionnaire [ Time Frame: assessed at 15 minutes after IUD insertion ] [ Designated as safety issue: No ]
Questions assessed in multiple choice format:
- Side effects
- injection site pain
- overall satisfaction with IUD insertion experience
- would they still recommend IUD placement to a friend?
- significant pain for which they desired acetaminophen prior to leaving the office?
- Post-insertion Provider Questionnaire [ Time Frame: Immediately after completion of IUD placement ] [ Designated as safety issue: No ]
The provider will be asked to fill out a multiple choice format questionnaire:
- what level training are you?
- which IUD was inserted?
- what was the purpose of IUD placement?
- what was the position of the uterus?
- did the IUD placement process require cervical dilation?
- were you unable to complete the IUD insertion?
- was there bleeding from the cervix that required more than 5 min to control?
- were there any major complications with the IUD insertion?
- did the patient take tylenol prior to leaving the office?
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo with 1cc normal saline IM
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Drug: Normal Saline
Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
Other Name: REF# 196604
Experimental: Toradol, 30mg in 1cc IM
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac 30mg intramuscular injection, 1cc volume
Modern intrauterine devices are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy (Zieman 2010). Fear of intrauterine device placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block compared to paracervical block alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement (Massey 1974). Studies to evaluate effectiveness of motrin and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous (Jensen 1998, Hubacher 2006, Saav 1997). There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed (Oloto 1996).
There have been no studies published to date regarding the use of ketorolac for decreasing pain during and after IUD placement. Ketorolac is an acetic acid NSAID that reversibly inhibits COX 1 and 2, leading to decreased formation of prostaglandin precursors, and is indicated for the use of moderate acute pain in the short term setting. Its administration in the office setting may be good option for providers since intramuscular administration leads to analgesia beginning at 30 minutes, maximal effect 1 to 2 hours after administration, and duration of analgesia approximately 4 to 6 hours for the 30mg intramuscular injection.
Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers at UCSD often suggest certain options. These include ibuprofen at least one hour prior to the procedure, or ibuprofen taken within a few hours after the procedure, or ketorolac injection at least 15-30 minutes prior to the procedure. It would be beneficial for providers to have an evidence based option for patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664559
|Contact: Lynn L Ngo, MDfirstname.lastname@example.org|
|Contact: Sheila Mody, MD MPH||619 email@example.com|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Sub-Investigator: Lynn Ngo, MD|
|Principal Investigator: Sheila Mody, MD MPH|
|Study Director:||Lynn L Ngo, MD||University of California, San Diego|
|Principal Investigator:||Sheila Mody, MD MPH||University of California, San Diego|