Naproxen for Pain Control With Intrauterine Device Insertion

NCT02388191 | Completed Results

• 1 other identifier: 2015P000436
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 1.To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
2. 2.To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
3. 3.To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Conditions

Contraception

Keywords

Contraception; Naproxen; Intrauterine devices; Pain Control

Outcome Measures

Primary Outcomes (1)

• Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)

  Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.

  Immediately after IUD insertion is complete

Secondary Outcomes (4)

• Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)

  Immediately after tenaculum is placed on cervix

• Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)

  Immediately after uterine sounding

• Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

  Five minutes after IUD insertion is complete

• Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

  Fifteen minutes after IUD insertion is complete

Study Arms (2)

Naproxen sodium

EXPERIMENTAL

550 mg naproxen sodium

Drug: Naproxen sodium

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo tablet

Interventions

Naproxen sodium DRUG

550 mg, oral, on day 1. Number of Cycles: 1

Naproxen sodium

Placebo tablet OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Premenopausal
• Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla)
• English-speaking or non-English speaking with appropriate translator available

You may not qualify if:

• Currently pregnant or pregnant within the last 4 weeks
• Not eligible for IUD insertion per PPLM's clinical protocols
• Presenting for IUD removal and reinsertion
• Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
• Pain medications taken within 12 hours of enrollment
• Misoprostol usage within 24 hours of enrollment
• Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)

Sponsors & Collaborators

• Planned Parenthood League of Massachusetts: lead

Study Sites (1)

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746.

  PMID: 27824753 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Naproxen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Principal Investigator
• Organization: Planned Parenthood League of Massachusetts

jfortin@pplm.org

6176298603

Study Officials

• Principal Investigator, MD, MPH

  PPLM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 22, 2017
• Results First Posted: June 22, 2017

Record last verified: 2017-06

Locations

US (1)