Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement

February 1, 2024 updated by: Shahwar Yousuf, Arkansas Children's Hospital Research Institute

Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial

Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement.

Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement..

The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients requiring sedated IUD placement at Arkansas Children's Hospital

Exclusion Criteria:

  • Allergy to ketorolac or other NDSAID
  • Known history of renal impairment
  • History of GI bleeding of peptic ulcer disease

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketorolac
The group of patients will receive IV Ketorolac before placement of IUD under sedation.
Drug: Ketorolac
Patients will get IV ketorolac during IUD placement under sedation
Other Names:
  • toradol
Placebo Comparator: Placebo
The group of patients will receive placebo before placement of IUD under sedation.
Drug: Placebo
Patients will get IV placebo during IUD placement under sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Post procedural pain after IUD placement
Time Frame: 24 hours
The primary outcome will be comparison of post-procedural pain using the Numerical Pain Rating Scale in ketorolac vs placebo group. The scale ranges from 0 to10 where 0 = no pain at all and 10= worst pain ever. Lower score indicates improvement in pain while a higher score indicates worsening of pain.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of propofol boluses required during sedation
Time Frame: 24 hours
24 hours
total propofol dose (mg/kg) given in each group
Time Frame: 24 hours
total propofol dose will be obtained from EHR and both groups will be compared for this purpose
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 275563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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