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IRB voted to terminate the protocol for noncompliance
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Hysterosalpingogram (HSG) testing is a vital part of the workup for infertility patients. It is often noted to be biggest pain that patients undergo during the workup. Several studies have attempted to find a therapy that reduces pain, with non-steroidal anti-inflammatory drugs such as oral ibuprofen the current mainstay. Our study attempts to determine which of the following NSAIDS is best at reducing pain associated with the HSG procedure: oral ibuprofen versus oral ketorolac .
Describe step-by-step how the study will be conducted from beginning to end
After IRB approval, the research pharmacist will provide motrin and ketorolac in identical packets labeled 1-88, after receiving the randomization strategy/number set from the research monitor.
REI physician on the protocol will screen patient for inclusion/exclusion from study at new patient consult or at future follow up visit when need for HSG is decided.
If patient pt screens eligible, discuss study. If elects participation then consent patient and randomize to group.
At time of scheduling HSG, patient will need to remind nursing that they are in HSG study. Nursing should also have the list of patients to reference when scheduling HSGs. Patients in the study will need to check in at the REI clinic 70 minutes prior to HSG in order to take their meds 60 minutes prior to scheduled procedure time. At same visit, REI RN will perform urine pregnancy test as previously scheduled.
a. meds will be kept in a locked cabinet in the REI research office in opaque sealed envelopes.
Patient will then go check into Radiology for their HSG.
HSG will be performed per standard clinical protocol. The HSG will be performed by REI physicians and OB/GYN residents (who are rotating on REI), which are the current standard of practice.
A nurse or provider associated with the study will need to be at the HSG for the sole purpose of study assistance. The provider performing the HSG, the study personnel recording pain levels, and the fluro tech will not be aware of the type of pre-procedural medication the patient received. The nurse or provider of study personnel will do the following:
7. For clarity- there will be at least three providers at each HSG for study enrolled patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 800mg ibuprofen 1 hour before HSG. |
|
| Ketorolac | Experimental | Patients randomized to this arm will receive an identical capsule to the other patient arm, and receive 30mg ketorolac 1 hour before HSG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 800 mg oral | Drug | 1 hour before HSG |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during contrast infiltration | Pain on Visual Analogue Scale (0-100) | Between 0 seconds and 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at baseline (before procedure start) | Pain on Visual Analogue Scale (0-100) | Between 0 seconds and 5 minutes |
| Pain with HSG catheter placement | Pain on Visual Analogue Scale (0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Pier | Madigan Chief of REI, Department of OBGYN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized controlled trial- 88 sequential patients randomized to receive either ibuprofen on ketorolac 1 hr before HSG
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Research pharmacist has provided either 800mg ibuprofen or 30mg ketorolac into oral capsules, and randomized sets of pills in packages 1-88. Research physicians and patients blinded which pill sets contain which drug. Will be revealed after data collection complete.
| Ketorolac 30mg oral | Drug | 1 hour before HSG |
|
|
| Between 0 seconds and 5 minutes |
| Pain at completion of HSG | Pain on Visual Analogue Scale (0-100) | Between 0 seconds and 5 minutes |
| Pain 5 minutes following HSG | Pain on Visual Analogue Scale (0-100) | 5 minutes after procedure |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D007213 |
| Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |