Background and Significance: IUDs are safe, effective, and reversible forms of
contraception. They are available in two forms in the United States: non-hormonal
(copper) and levonorgestrel hormonal devices. There are very few contraindications to
placement and few associated side effects. Despite these facts, only 14% of women aged
15-44 currently use an IUD1. Data over recent years show an increase in IUD usage among
younger women, and the American College of Obstetricians and Gynecologists (ACOG) support
use in adolescent patients, many of which seek care from pediatric providers2. IUDs are
easy to place and remove, with most procedures occurring in the office setting.
One barrier to more widespread use of IUDs may be the perception of pain associated with
insertion, especially among younger patients. One study of 100 nulligravid women reported
a 78% incidence of "moderate" or "severe" pain with IUD placement3. Several studies have
evaluated various methods to attenuate the pain and anxiety associated with IUD
placement, including behavioral interventions4, topical and injectable lidocaine applied
to the cervix5,6, and injectable medications7. The ACOG currently recommends taking
over-the-counter pain medications prior to IUD placement, though no specific medications
are mentioned. Some adolescent patients require procedural sedation due to perceived
pain, previous unsuccessful office procedures, developmental delay, and chronic pelvic
pain, among other indications.
Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID), available in oral and
injectable forms. It is used for moderately severe pain, often after an operation or
painful procedure. Time to onset of analgesia with injectable ketorolac (IV or IM) is
approximately 30 minutes, with maximum effect at 1-2 hours, and a median duration of 6
hours. Ketorolac, given orally or as an intramuscular injection (IM), has been shown to
effectively attenuate the pain associated with in-office placement of IUDs7,8. We
hypothesize that the administration of IV ketorolac, given during sedation for IUD
placement, will lead to a decrease in post-procedural pain.
Project Design and Methods: A randomized, double-blind, placebo-controlled trial will
test the stated hypotheses associated with the specific aims above. All patients
undergoing IUD placement under sedation, provided by the pediatric critical care sedation
service at Arkansas Children's Hospital (ACH), will be eligible for enrollment. Patients
meeting inclusion/exclusion criteria (see below) will be randomized to ketorolac or
placebo after providing informed consent/assent. IUD placement will be performed by the
pediatric gynecology service at ACH, using one of two levonorgestrel devices (Kyleena or
Mirena). In addition to the study drug, propofol will be used for sedation. All subjects
will be sedated with propofol in the following manner: 1mg/kg IV loading dose (10mg
additional doses to achieve sedation), followed by a 150mcg/kg/min infusion rate during
the procedure. Additional 10mg boluses will be given at the discretion of the seditionist
(Pediatric Critical Care Medicine or Pediatric Emergency Medicine physician) and will be
recorded for comparison as a secondary outcome measure.
Study Drug and Randomization Procedure: All eligible subjects will be randomized to
ketorolac or placebo using simple randomization. A randomization schedule will be
constructed using a random number generator. The study pharmacist will dispense ketorolac
or placebo based on the randomization schedule. All study investigators and clinical
staff will be blinded to group assignment. Ketorolac and placebo will be dispensed in
identical syringes in identical volumes. Study drug will be administered intravenously by
the sedation nurse at least 30 minutes prior to the start of sedation for IUD placement.