Naproxen for Pain Control With Intrauterine Device Insertion

Contraception Clinical Trial

Official title:

Naproxen for Pain Control With Intrauterine Device Insertion: A Randomized Double-Blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388191
• Other study ID #: 2015P000436
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: June 20, 2017
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2017
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is:

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. 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. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Naproxen sodium
550 mg, oral, on day 1. Number of Cycles: 1

Other:
• Placebo tablet

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)	Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (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 tenaculum is placed on cervix
Secondary	Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)	Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (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 uterine sounding
Secondary	Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)	Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (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.	Five minutes after IUD insertion is complete
Secondary	Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)	Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (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.	Fifteen minutes after IUD insertion is complete