Completed

Pain Control for Intrauterine Device Placement: A Randomized, Double Blind Control Trial of Ketorolac Prior to Intrauterine Device Placement.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Normal Saline

+ Ketorolac

Drug
Who is being recruted

Nervous System Diseases+4

+ Neurologic Manifestations

+ Perceptual Disorders

From 18 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorLynn Ngo
Last updated: December 23, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorLynn Ngo
Last updated: December 23, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

67 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeurologic ManifestationsPerceptual DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsAgnosia

Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.

Group II

Experimental
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California San Diego

San Diego, United StatesOpen University of California San Diego in Google Maps
CompletedOne Study Center