Contraception, Pain
Conditions
Keywords
naproxen, lidocaine, intrauterine device, IUD, pain
Brief summary
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.
Detailed description
This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate. The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.
Interventions
DRUGNaproxen
Oral naproxen vs placebo
DRUGLidocaine
Intrauterine lidocaine vs normal saline
DRUGplacebo
either normal saline or empty oral capsule
Sponsors
Walter Reed National Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* DEERS-eligible reproductive age women (i.e. Tricare beneficiaries) * age 18 years and older * desiring Paragard or Mirena intrauterine device insertion
Exclusion criteria
* Current pregnancy * cervical stenosis * severe medical illness * known allergy or sensitivity to lidocaine or naproxen * peptic ulcer disease * current pelvic inflammatory disease * patients with known renal insufficiency * patients using chronic NSAIDs or on chronic pain medication * women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Control With IUD Insertion | within 30 minutes after IUD 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Perceived Pain Control During IUD Insertion | within 30 minutes after IUD insertion | 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 |
| Patient Satisfaction With IUD | 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. |
| Difficulty IUD Insertion | within 30 minutes of IUD insertion | as rated by the physician. Very easy/easy were rated as easy whereas difficult/very difficult is difficult. |
| Perceived Pain 30 Days Post Insertion | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion
placebo: either normal saline or empty oral capsule | 39 |
| 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 | 40 |
| 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 | 39 |
| Naproxen/Lidocaine Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion
Naproxen: Oral naproxen vs placebo
Lidocaine: Intrauterine lidocaine vs normal saline | 39 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Naproxen/Normal Saline | Placebo Oral Medication/Lidocaine | Naproxen/Lidocaine | Placebo |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 157 Participants | 40 Participants | 39 Participants | 39 Participants | 39 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 157 Participants | 40 Participants | 39 Participants | 39 Participants | 39 Participants |
| Sex: Female, Male Female | 157 Participants | 40 Participants | 39 Participants | 39 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 40 | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 40 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 | 0 / 39 | 0 / 39 |
Outcome results
Primary
Pain Control With IUD 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
Time frame: within 30 minutes after IUD insertion
Population: There is one patient in placebo arm that did not receive IUD due to difficulty with insertion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain Control With IUD Insertion | 3.606 units on a scale | Standard Error 0.372 |
| Naproxen/Normal Saline | Pain Control With IUD Insertion | 3.088 units on a scale | Standard Error 0.367 |
| Placebo Oral Medication/Lidocaine | Pain Control With IUD Insertion | 2.83 units on a scale | Standard Error 0.372 |
| Naproxen/Lidocaine | Pain Control With IUD Insertion | 3.382 units on a scale | Standard Error 0.372 |
Secondary
Difficulty IUD Insertion
as rated by the physician. Very easy/easy were rated as easy whereas difficult/very difficult is difficult.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Difficulty IUD Insertion | Easy | 36 Participants |
| Placebo | Difficulty IUD Insertion | Difficult | 2 Participants |
| Naproxen/Normal Saline | Difficulty IUD Insertion | Difficult | 2 Participants |
| Naproxen/Normal Saline | Difficulty IUD Insertion | Easy | 38 Participants |
| Placebo Oral Medication/Lidocaine | Difficulty IUD Insertion | Difficult | 1 Participants |
| Placebo Oral Medication/Lidocaine | Difficulty IUD Insertion | Easy | 38 Participants |
| Naproxen/Lidocaine | Difficulty IUD Insertion | Difficult | 1 Participants |
| Naproxen/Lidocaine | Difficulty IUD Insertion | Easy | 38 Participants |
Secondary
Patient Satisfaction With IUD
Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.
Time frame: 30 days post insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Satisfaction With IUD | 4.423 units on a scale | Standard Error 0.16 |
| Naproxen/Normal Saline | Patient Satisfaction With IUD | 4.325 units on a scale | Standard Error 0.145 |
| Placebo Oral Medication/Lidocaine | Patient Satisfaction With IUD | 4.264 units on a scale | Standard Error 0.153 |
| Naproxen/Lidocaine | Patient Satisfaction With IUD | 4.358 units on a scale | Standard Error 0.147 |
Secondary
Perceived Pain 30 Days Post 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).
Time frame: 30 days post IUD insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Perceived Pain 30 Days Post Insertion | 3.12 units on a scale | Standard Error 0.4 |
| Naproxen/Normal Saline | Perceived Pain 30 Days Post Insertion | 2.97 units on a scale | Standard Error 0.43 |
| Placebo Oral Medication/Lidocaine | Perceived Pain 30 Days Post Insertion | 3.2 units on a scale | Standard Error 0.48 |
| Naproxen/Lidocaine | Perceived Pain 30 Days Post Insertion | 3.04 units on a scale | Standard Error 0.42 |
Secondary
Physician Perceived Pain Control During IUD Insertion
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Physician Perceived Pain Control During IUD Insertion | .59 units on a scale | Standard Deviation 0.8 |
| Naproxen/Normal Saline | Physician Perceived Pain Control During IUD Insertion | .48 units on a scale | Standard Deviation 0.11 |
| Placebo Oral Medication/Lidocaine | Physician Perceived Pain Control During IUD Insertion | .56 units on a scale | Standard Deviation 0.09 |
| Naproxen/Lidocaine | Physician Perceived Pain Control During IUD Insertion | .77 units on a scale | Standard Deviation 0.11 |
Post Hoc
Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30
Assessment at day 30 if patients used analgesics within 24 hrs post Mirena IUD insertion
Time frame: 30 days
Population: These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | Yes, used analgesics | 5 Participants |
| Placebo | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | No analgesics used | 11 Participants |
| Naproxen/Normal Saline | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | No analgesics used | 15 Participants |
| Naproxen/Normal Saline | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | Yes, used analgesics | 5 Participants |
| Placebo Oral Medication/Lidocaine | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | Yes, used analgesics | 3 Participants |
| Placebo Oral Medication/Lidocaine | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | No analgesics used | 15 Participants |
| Naproxen/Lidocaine | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | Yes, used analgesics | 3 Participants |
| Naproxen/Lidocaine | Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30 | No analgesics used | 16 Participants |
Post Hoc
Paragard IUD Medication Use 30 Day Assessment
Assessment of whether patient had used analgesics in first 24 hrs after Paragard IUD insertion. Quantified yes or no.
Time frame: 30 days
Population: These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Paragard IUD Medication Use 30 Day Assessment | Yes, used analgesics | 7 Participants |
| Placebo | Paragard IUD Medication Use 30 Day Assessment | No medication use | 10 Participants |
| Naproxen/Normal Saline | Paragard IUD Medication Use 30 Day Assessment | No medication use | 16 Participants |
| Naproxen/Normal Saline | Paragard IUD Medication Use 30 Day Assessment | Yes, used analgesics | 4 Participants |
| Placebo Oral Medication/Lidocaine | Paragard IUD Medication Use 30 Day Assessment | Yes, used analgesics | 5 Participants |
| Placebo Oral Medication/Lidocaine | Paragard IUD Medication Use 30 Day Assessment | No medication use | 13 Participants |
| Naproxen/Lidocaine | Paragard IUD Medication Use 30 Day Assessment | Yes, used analgesics | 7 Participants |
| Naproxen/Lidocaine | Paragard IUD Medication Use 30 Day Assessment | No medication use | 10 Participants |
Post Hoc
Paragard vs Mirena IUD
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.
Time frame: visual analog scale as assessed by patient and physician both within 30 minutes post insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Paragard vs Mirena IUD | 3.02 units on a scale | Standard Error 0.25 |
| Naproxen/Normal Saline | Paragard vs Mirena IUD | 3.49 units on a scale | Standard Error 0.25 |
Post Hoc
Paragard vs Mirena IUD Pain Medication Use
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Paragard vs Mirena IUD Pain Medication Use | Medication used postprocedure | 16 Participants |
| Placebo | Paragard vs Mirena IUD Pain Medication Use | No medication use post procedure | 57 Participants |
| Naproxen/Normal Saline | Paragard vs Mirena IUD Pain Medication Use | Medication used postprocedure | 23 Participants |
| Naproxen/Normal Saline | Paragard vs Mirena IUD Pain Medication Use | No medication use post procedure | 49 Participants |