Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement

NCT01664559 | Completed Results

• 1 other identifier: WRHR 5K12001259-12 - toradol
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Control With IUD Insertion

Keywords

intrauterine device; ketorolac; toradol; mirena; paragard; pain control

Outcome Measures

Primary Outcomes (1)

• VAS (Visual Analogue Scale) Measurement of Pain

  The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.

  Pain with IUD placement, measured immediately after placement

Secondary Outcomes (4)

• Pain Scores at Other Time Points During and After IUD Placement

  immediately after each step (see description)

• Nulliparous Patients - Subgroup Analysis

  immediately after each step (see description)

• Post-insertion Patient Questionnaire

  assessed at 15 minutes after IUD insertion

• Post-insertion Provider Questionnaire

  Immediately after IUD placement, on average within 1 hour

Study Arms (2)

Placebo with 1cc normal saline IM

PLACEBO COMPARATOR

If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.

Drug: Normal Saline

Toradol, 30mg in 1cc IM

EXPERIMENTAL

If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.

Drug: Ketorolac

Interventions

Ketorolac DRUG

Ketorolac 30mg intramuscular injection, 1cc volume

Also known as: Brand name: toradol, Serial # (01) 1 030409 379649 7

Toradol, 30mg in 1cc IM

Normal Saline DRUG

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

Also known as: REF# 196604

Placebo with 1cc normal saline IM

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

You may not qualify if:

• Pregnancy
• Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
• If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
• Misoprostol administration within 24 hours of enrollment
• History of prior IUD insertion
• Known allergy to NSAIDs including diagnosis of aspirin or NSAID induced asthma or urticaria
• Known contraindications to NSAIDs, such as the following medications that are risk category D (consider therapy modification) or X (avoid combination) including
• bile acid sequestrants (D - may decrease absorption of NSAIDs)
• cyclosporine (D - NSAIDs may enhance the nephrotoxic effects)
• drotrecogin alfa (D - NSAIDs may enhance the adverse/toxic effects, cause bleeding)
• floctafenine (X - may enhance adverse/toxic effect of NSAIDs)
• lithium (D - NSAIDs may decrease serum concentration)
• methotrexate (D - NSAIDs may decrease excretion)
• pentoxifylline (X - Ketorolac may enhance adverse/toxic effects)
• probenecid (X - may increase serum concentration of Ketorolac)

Sponsors & Collaborators

• Lynn Ngo: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92103, United States

Location

Related Publications (4)

• Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.

  PMID: 19588429 BACKGROUND

• Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.

  PMID: 22133656 BACKGROUND

• Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.

  PMID: 21843686 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 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Ketorolac; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Lynn Ngo, Lead Study Coordinator/investigator
• Organization: BWH

llngo@partners.org

(617)732-8798

Study Officials

• Lynn L Ngo, MD

  University of California, San Diego

  STUDY DIRECTOR

• Sheila Mody, MD MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: August 14, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 23, 2015
• Results First Posted: December 23, 2015

Record last verified: 2015-11

Locations

US (1)