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

NCT05875571 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 275563
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IUD; Healthy Female; Contraception; IUD Insertion Complication

Outcome Measures

Primary Outcomes (1)

• Comparison of Post procedural pain after IUD placement

  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 Outcomes (2)

• number of propofol boluses required during sedation

  24 hours

• total propofol dose (mg/kg) given in each group

  24 hours

Study Arms (2)

Ketorolac

ACTIVE COMPARATOR

The group of patients will receive IV Ketorolac before placement of IUD under sedation.

Drug: Ketorolac

Placebo

PLACEBO COMPARATOR

The group of patients will receive placebo before placement of IUD under sedation.

Drug: Placebo

Interventions

Ketorolac DRUG

Patients will get IV ketorolac during IUD placement under sedation

Also known as: toradol

Ketorolac

Placebo DRUG

Patients will get IV placebo during IUD placement under sedation

Placebo

Eligibility Criteria

• Age: 13 Years - 21 Years
• Gender Eligibility Details: Female adolescent patients undergoing IUD placement
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Childrens Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Related Publications (9)

• Jatlaoui TC, Riley HEM, Curtis KM. The safety of intrauterine devices among young women: a systematic review. Contraception. 2017 Jan;95(1):17-39. doi: 10.1016/j.contraception.2016.10.006. Epub 2016 Oct 19.

  PMID: 27771475 BACKGROUND

• Hall AM, Kutler BA. Intrauterine contraception in nulliparous women: a prospective survey. J Fam Plann Reprod Health Care. 2016 Jan;42(1):36-42. doi: 10.1136/jfprhc-2014-101046. Epub 2015 Apr 8.

  PMID: 25854550 BACKGROUND

• Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30.

  PMID: 31666302 BACKGROUND

• Panichyawat N, Mongkornthong T, Wongwananuruk T, Sirimai K. 10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial. BMJ Sex Reprod Health. 2021 Jul;47(3):159-165. doi: 10.1136/bmjsrh-2020-200670. Epub 2020 Jun 26.

  PMID: 32591417 BACKGROUND

• Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.

  PMID: 30095776 BACKGROUND

• Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.

  PMID: 26241253 BACKGROUND

• Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. J Obstet Gynaecol Can. 2017 Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014. Epub 2017 Aug 18.

  PMID: 28826645 BACKGROUND

• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.

  PMID: 29321111 BACKGROUND

• Chaves IA, Baeta T, Dolabella GB, Barbosa LR, Almeida NM, Oliveira FR, Oliveira EC, L Silva-Filho A, Rocha ALL. Pain scores at the insertion of the 52 MG levonorgestrel-releasing intrauterine system among nulligravidas and parous women. Eur J Contracept Reprod Health Care. 2021 Oct;26(5):399-403. doi: 10.1080/13625187.2021.1925882. Epub 2021 Jun 7.

  PMID: 34096433 BACKGROUND

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Shahwar Yousuf, MD

CONTACT

501-364-1341; syousuf@uams.edu

Jill Gassaway

CONTACT

501-364-2862; GassawayJA@archildrens.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The provider and participant will be masked and will not know if the patient is getting the study drug or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Critical Care Fellow

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 25, 2023
• Study Start: February 5, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)