CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Ketorolac +1 moredrug
Likely dose
Ketorolac 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01664559
NCT01664559N/ACompleted

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

Lynn Ngo·interventional·Posted Aug 14, 2012·Updated Dec 23, 2015

In Brief

A clinical study evaluating Ketorolac and Normal Saline for Pain Control With IUD Insertion. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 14, 2012
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.9 years ago

Interventions

Ketorolacdrug

Ketorolac 30mg intramuscular injection, 1cc volume

Normal Salinedrug

Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection