Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement
Condition: Pain Control With IUD Insertion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ketorolac; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Ketorolac 30mg intramuscular injection, 1cc volume; Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
Other intervention name(s): Brand name: toradol; Serial # (01) 1 030409 379649 7; REF# 196604
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intrauterine device; ketorolac; toradol; mirena; paragard; pain control