Trial Outcomes & Findings for Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion (NCT NCT02769247)

Results Overview

visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

within 30 minutes after IUD insertion

Results posted on

2018-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Overall Study STARTED	40	40	40	40
Overall Study COMPLETED	38	40	39	39
Overall Study NOT COMPLETED	2	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Overall Study Withdrawal by Subject	1	0	1
Overall Study Protocol Violation	0	1	0
Overall Study Physician Decision	1	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=39 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=40 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=39 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=39 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline	Total n=157 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=39 Participants	0 Participants n=157 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=39 Participants	40 Participants n=40 Participants	39 Participants n=39 Participants	39 Participants n=39 Participants	157 Participants n=157 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=39 Participants	0 Participants n=157 Participants
Sex: Female, Male Female	39 Participants n=39 Participants	40 Participants n=40 Participants	39 Participants n=39 Participants	39 Participants n=39 Participants	157 Participants n=157 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=40 Participants	0 Participants n=39 Participants	0 Participants n=39 Participants	0 Participants n=157 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	39 Participants n=39 Participants	40 Participants n=40 Participants	39 Participants n=39 Participants	39 Participants n=39 Participants	157 Participants n=157 Participants

PRIMARY outcome

Timeframe: within 30 minutes after IUD insertion

Population: There is one patient in placebo arm that did not receive IUD due to difficulty with insertion.

visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=40 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=39 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=39 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Pain Control With IUD Insertion	3.606 units on a scale Standard Error .372	3.088 units on a scale Standard Error .367	2.83 units on a scale Standard Error .372	3.382 units on a scale Standard Error .372

SECONDARY outcome

Timeframe: within 30 minutes after IUD insertion

Population: There was one patient in placebo arm unable to have her IUD placed due to difficulty with insertion. She was removed from the analysis.

visual analog scale (0-3) as assessed by physician within 30 minutes after IUD insertion Scale is from a minimum of 0, with maximum of 3 with higher scores denoting more pain

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=40 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=39 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=39 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Physician Perceived Pain Control During IUD Insertion	.59 units on a scale Standard Deviation .8	.48 units on a scale Standard Deviation .11	.56 units on a scale Standard Deviation .09	.77 units on a scale Standard Deviation .11

SECONDARY outcome

Timeframe: 30 days post insertion

Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=40 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=39 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=39 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Patient Satisfaction With IUD	4.423 units on a scale Standard Error .16	4.325 units on a scale Standard Error .145	4.264 units on a scale Standard Error .153	4.358 units on a scale Standard Error .147

SECONDARY outcome

Timeframe: within 30 minutes of IUD insertion

Population: Overall number of participants analyzed for placebo arm is different due to 1 of the subjects not able to have their IUD inserted due to difficulty of procedure. They were included in this analysis as an attempt had been made to insert device.

as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=40 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=39 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=39 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Difficulty IUD Insertion Easy	36 Participants	38 Participants	38 Participants	38 Participants
Difficulty IUD Insertion Difficult	2 Participants	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days post IUD insertion

survey patient 30 days later to determine her recollection of pain during insertion (0-10); 10 being the most pain. One patient had no IUD initially inserted and was not included; each arm had patients lost to follow up (3 in placebo arm, 2 in naproxen arm, 4 in placebo/oral medication arm).

Outcome measures

Outcome measures
Measure	Placebo n=33 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=38 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=35 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=39 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Perceived Pain 30 Days Post Insertion	3.12 units on a scale Standard Error .40	2.97 units on a scale Standard Error .43	3.2 units on a scale Standard Error .48	3.04 units on a scale Standard Error .42

POST_HOC outcome

Timeframe: visual analog scale as assessed by patient and physician both within 30 minutes post insertion

difference in pain ratings during IUD insertion as assessed by visual analog scale by both patient (0-10 with 10 being the most pain, 0 no pain) within 30 minutes post insertion classified by IUD type. This measure is made to address whether type of IUD affected pain perception.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=77 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Paragard vs Mirena IUD	3.02 units on a scale Standard Error .25	3.49 units on a scale Standard Error .25	—	—

POST_HOC outcome

Timeframe: 30 days post insertion

Population: These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.

Patient's recall of self administered pain medication within 24 hours after IUD insertion as reported 30 days post insertion. Denoted as "yes " or "no". This measure was to assess whether any difference in pain perception between patients receiving different types of IUD.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=72 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Paragard vs Mirena IUD Pain Medication Use Medication used postprocedure	16 Participants	23 Participants	—	—
Paragard vs Mirena IUD Pain Medication Use No medication use post procedure	57 Participants	49 Participants	—	—

POST_HOC outcome

Timeframe: 30 days

Population: These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.

Assessment of whether patient had used analgesics in first 24 hrs after Paragard IUD insertion. Quantified yes or no.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=20 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=18 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=17 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Paragard IUD Medication Use 30 Day Assessment Yes, used analgesics	7 Participants	4 Participants	5 Participants	7 Participants
Paragard IUD Medication Use 30 Day Assessment No medication use	10 Participants	16 Participants	13 Participants	10 Participants

POST_HOC outcome

Timeframe: 30 days

Population: These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.

Assessment at day 30 if patients used analgesics within 24 hrs post Mirena IUD insertion

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule	Naproxen/Normal Saline n=20 Participants Patient will receive naproxen and intrauterine normal saline prior to IUD insertion Naproxen: Oral naproxen vs placebo placebo: either normal saline or empty oral capsule	Placebo Oral Medication/Lidocaine n=18 Participants Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion Lidocaine: Intrauterine lidocaine vs normal saline placebo: either normal saline or empty oral capsule	Naproxen/Lidocaine n=19 Participants Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline
Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 No analgesics used	11 Participants	15 Participants	15 Participants	16 Participants
Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 Yes, used analgesics	5 Participants	5 Participants	3 Participants	3 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Naproxen/Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Oral Medication/Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Naproxen/Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shana Miles

Walter Reed National Military Medical Center

Phone: 318 456 6389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place