Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement
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| ClinicalTrials.gov Identifier: NCT05875571 |
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Recruitment Status :
Recruiting
First Posted : May 25, 2023
Last Update Posted : February 5, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| IUD Healthy Female Contraception IUD Insertion Complication | Drug: Ketorolac Drug: Placebo | Phase 4 |
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 (Clinical Trial) |
| Estimated Enrollment : | 18 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | The provider and participant will be masked and will not know if the patient is getting the study drug or placebo |
| Primary Purpose: | Treatment |
| Official Title: | Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial |
| Estimated Study Start Date : | February 5, 2024 |
| Estimated Primary Completion Date : | April 2025 |
| Estimated Study Completion Date : | June 2025 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Ketorolac
The group of patients will receive IV Ketorolac before placement of IUD under sedation.
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Drug: Ketorolac
Patients will get IV ketorolac during IUD placement under sedation
Other Name: toradol |
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Placebo Comparator: Placebo
The group of patients will receive placebo before placement of IUD under sedation.
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Drug: Placebo
Patients will get IV placebo during IUD placement under sedation |
- 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.
- number of propofol boluses required during sedation [ Time Frame: 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
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| Ages Eligible for Study: | 13 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Female adolescent patients undergoing IUD placement |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05875571
| Contact: Shahwar Yousuf, MD | 501-364-1341 | syousuf@uams.edu | |
| Contact: Jill Gassaway | 501-364-2862 | GassawayJA@archildrens.org |
| United States, Arkansas | |
| Arkansas Childrens Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Shahwar Yousuf 501-364-1341 syousuf@uams.edu | |
| Contact: Lee Crawley crawleylj@archildrens.org | |
| Responsible Party: | Shahwar Yousuf, Principal Investigator, Pediatric Critical Care Fellow, Arkansas Children's Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT05875571 |
| Other Study ID Numbers: |
275563 |
| First Posted: | May 25, 2023 Key Record Dates |
| Last Update Posted: | February 5, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Pain, Procedural Pain Neurologic Manifestations Ketorolac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |