Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement

Completed · Not applicable · Has a placebo group

Conditions studied: Pain Control With IUD Insertion

In brief

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.

Key facts

Study ID

NCT01664559

Run by

Lynn Ngo

People needed

67

Starts

2012-07-01

Expected to finish

2014-03-01

Last updated by the study team

2015-12-23

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

You may not qualify if…

• Pregnancy
• Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
• If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
• Misoprostol administration within 24 hours of enrollment
• History of prior IUD insertion
• Known allergy to NSAIDs including diagnosis of aspirin or NSAID induced asthma or urticaria
• Known contraindications to NSAIDs, such as the following medications that are risk category D (consider therapy modification) or X (avoid combination) including
• bile acid sequestrants (D - may decrease absorption of NSAIDs)
• cyclosporine (D - NSAIDs may enhance the nephrotoxic effects)
• drotrecogin alfa (D - NSAIDs may enhance the adverse/toxic effects, cause bleeding)
• floctafenine (X - may enhance adverse/toxic effect of NSAIDs)
• lithium (D - NSAIDs may decrease serum concentration)
• methotrexate (D - NSAIDs may decrease excretion)
• pentoxifylline (X - Ketorolac may enhance adverse/toxic effects)
• probenecid (X - may increase serum concentration of Ketorolac)
• rivaroxaban (D - Anti-platelet drugs may enhance anti-coagulation effect)
• SSRIs (D - may enhance the anti-platelet effect of NSAIDs, NSAIDs may diminish the therapeutic effect of SSRIs)
• warfarin (D - NSAIDs may enhance the anti-coagulation effect)
• Renal insufficiency (by history and/or chart review)
• Peptic ulcer disease or history of significant gastrointestinal bleeding
• Known thrombocytopenia, known coagulopathy, or known bleeding disorder
• Known contraindications to IUD

Where it is running

• University of California San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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