Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion |
|
| Naproxen/Normal saline | Experimental | Patient will receive naproxen and intrauterine normal saline prior to IUD insertion |
|
| Placebo oral medication/Lidocaine | Experimental | Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion |
|
| Naproxen/Lidocaine | Experimental | Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Oral naproxen vs placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 30 minutes after IUD insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 30 minutes after IUD insertion |
| Patient Satisfaction With IUD |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Dunlow, MD | WRNMMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31516731 | Derived | Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Naproxen/Lidocaine | Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule |
| BG001 | Naproxen/Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | There is one patient in placebo arm that did not receive IUD due to difficulty with insertion. | Posted | Mean | Standard Error | units on a scale | within 30 minutes after IUD insertion |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion placebo: either normal saline or empty oral capsule |
Not provided
Not provided
Sample size is limitation. Single site conducting study using single insurance payer.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shana Miles | Walter Reed National Military Medical Center | 318 456 6389 | shana.m.miles2.mil@mail.mil |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009288 | Naproxen |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine |
| Drug |
Intrauterine lidocaine vs normal saline |
|
| placebo | Drug | either normal saline or empty oral capsule |
|
Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied. |
| 30 days post insertion |
| Difficulty IUD Insertion | as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult. | within 30 minutes of IUD insertion |
| 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). | 30 days post IUD insertion |
| Protocol Violation |
|
| Physician Decision |
|
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
| BG002 | 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 |
| BG003 | Naproxen/Lidocaine | Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | Naproxen/Lidocaine | Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline |
|
|
| 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 | There was one patient in placebo arm unable to have her IUD placed due to difficulty with insertion. She was removed from the analysis. | Posted | Mean | Standard Deviation | units on a scale | within 30 minutes after IUD insertion |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 30 days post insertion |
|
|
|
| Secondary | Difficulty IUD Insertion | as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult. | 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. | Posted | Count of Participants | Participants | within 30 minutes of IUD insertion |
|
|
|
| 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). | Posted | Mean | Standard Error | units on a scale | 30 days post IUD insertion |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | visual analog scale as assessed by patient and physician both within 30 minutes post insertion |
|
|
|
| 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. | These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion. | Posted | Count of Participants | Participants | 30 days post insertion |
|
|
|
| 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. | These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 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 | These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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 | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | 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 | 0 | 39 | 0 | 39 | 0 | 39 |
| EG003 | Naproxen/Lidocaine | Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion Naproxen: Oral naproxen vs placebo Lidocaine: Intrauterine lidocaine vs normal saline | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Difficult |
|
| No medication use |
|
| No analgesics used |
|