Pain Control With IUD InsertionNCT01664559
Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement
A study testing Ketorolac and Normal Saline in people with Pain Control With IUD Insertion, run by Lynn Ngo at 1 site in United States.
Trial summary
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Control With IUD Insertion
- What is being tested?
- Ketorolac and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).
Who cannot join
- Pregnancy
- Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
- If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
- Misoprostol administration within 24 hours of enrollment
- History of prior IUD insertion
- Known allergy to NSAIDs including diagnosis of aspirin or NSAID induced asthma or urticaria
Show all 22Show fewer
- Known contraindications to NSAIDs, such as the following medications that are risk category D (consider therapy modification) or X (avoid combination) including
- bile acid sequestrants (D - may decrease absorption of NSAIDs)
- cyclosporine (D - NSAIDs may enhance the nephrotoxic effects)
- drotrecogin alfa (D - NSAIDs may enhance the adverse/toxic effects, cause bleeding)
- floctafenine (X - may enhance adverse/toxic effect of NSAIDs)
- lithium (D - NSAIDs may decrease serum concentration)
- methotrexate (D - NSAIDs may decrease excretion)
- pentoxifylline (X - Ketorolac may enhance adverse/toxic effects)
- probenecid (X - may increase serum concentration of Ketorolac)
- rivaroxaban (D - Anti-platelet drugs may enhance anti-coagulation effect)
- SSRIs (D - may enhance the anti-platelet effect of NSAIDs, NSAIDs may diminish the therapeutic effect of SSRIs)
- warfarin (D - NSAIDs may enhance the anti-coagulation effect)
- Renal insufficiency (by history and/or chart review)
- Peptic ulcer disease or history of significant gastrointestinal bleeding
- Known thrombocytopenia, known coagulopathy, or known bleeding disorder
- Known contraindications to IUD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92103
About this study
Official title: Pain Control for Intrauterine Device Placement: A Randomized, Double Blind Control Trial of Ketorolac Prior to Intrauterine Device Placement.
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.
Read the detailed description
Modern intrauterine devices are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy (Zieman 2010). Fear of intrauterine device placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block compared to paracervical block alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement (Massey 1974). Studies to evaluate effectiveness of motrin and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous (Jensen 1998, Hubacher 2006, Saav 1997). There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed (Oloto 1996).
There have been no studies published to date regarding the use of ketorolac for decreasing pain during and after IUD placement. Ketorolac is an acetic acid NSAID that reversibly inhibits COX 1 and 2, leading to decreased formation of prostaglandin precursors, and is indicated for the use of moderate acute pain in the short term setting. Its administration in the office setting may be good option for providers since intramuscular administration leads to analgesia beginning at 30 minutes, maximal effect 1 to 2 hours after administration, and duration of analgesia approximately 4 to 6 hours for the 30mg intramuscular injection.
Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers at UCSD often suggest certain options. These include ibuprofen at least one hour prior to the procedure, or ibuprofen taken within a few hours after the procedure, or ketorolac injection at least 15-30 minutes prior to the procedure. It would be beneficial for providers to have an evidence based option for patients.
- Conditions
- Pain Control With IUD Insertion
- Being tested
- Ketorolac, Normal Saline
- Keywords
- intrauterine device, ketorolac, toradol, mirena, paragard, pain control
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Brand name: toradol, Serial # (01) 1 030409 379649 7
Ketorolac 30mg intramuscular injection, 1cc volume
Normal SalineDrug
Also called REF# 196604
Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo with 1cc normal saline IM | Placebo comparator | If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route. Receives: Drug: Normal Saline |
| Toradol, 30mg in 1cc IM | Experimental | If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analogue Scale) Measurement of Pain
The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Measured: Pain with IUD placement, measured immediately after placement
Secondary outcomes (4)
Pain Scores at Other Time Points During and After IUD Placement
The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
- Prior to injection of study drug, anticipated pain
- Pain from study drug injection, measured immediately after injection
- Pain from speculum insertion, measured immediately after insertion
- Pain with tenaculum placement, measured immediately after placement
- Pain with uterine sounding, measured immediately after removal of the sound
- Pain at 5 minutes after placement of the intrauterine device
- Pain at 15 minutes after placement of the intrauterine device
Measured: immediately after each step (see description)
Nulliparous Patients - Subgroup Analysis
The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
- Prior to injection of study drug, anticipated pain
- Pain from study drug injection, measured immediately after injection
- Pain from speculum insertion, measured immediately after insertion
- Pain with tenaculum placement, measured immediately after placement
- Pain with uterine sounding, measured immediately after removal of the sound
- Pain at 5 minutes after placement of the intrauterine device
- Pain at 15 minutes after placement of the intrauterine device
Measured: immediately after each step (see description)
Post-insertion Patient Questionnaire
Questions assessed in multiple choice format:
- Side effects
- injection site pain
- overall satisfaction with IUD insertion experience
- would they still recommend IUD placement to a friend?
- significant pain for which they desired acetaminophen prior to leaving the office?
Measured: assessed at 15 minutes after IUD insertion
Post-insertion Provider Questionnaire
The provider will be asked to fill out a multiple choice format questionnaire:
- what level training are you?
- which IUD was inserted?
- what was the purpose of IUD placement?
- what was the position of the uterus?
- did the IUD placement process require cervical dilation?
- were you able to complete the IUD insertion?
- was there bleeding from the cervix that required more than 5 min to control?
- were there any major complications with the IUD insertion?
- did the patient take tylenol prior to leaving the office?
Measured: Immediately after IUD placement, on average within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain Control With IUD InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynn Ngo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lynn Ngo, University of California, San Diego
- Investigators
- Lynn L Ngo, MD, Study director, University of California, San DiegoSheila Mody, MD MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664559
- Sponsor's protocol ID
- WRHR 5K12001259-12 - toradol
- Status last verified
- Nov 2015
- First submitted
- 28 Jun 2012
- Last updated
- 23 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
PubMed 19588429Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.
PubMed 22133656Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.
PubMed 21843686Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.
PubMed 26241253
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control for Intrauterine Device Placement: A Randomized, Double Blind Control Trial of Ketorolac Prior to Intrauterine Device Placement.
- ClinicalTrials.gov ID
- NCT01664559
- Acronym / sponsor ID
- WRHR 5K12001259-12 - toradol
- Conditions
- Pain Control With IUD Insertion
- Keywords
- intrauterine device, ketorolac, toradol, mirena, paragard, pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Lynn NgoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Posted 23 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs (Mirena IUD and Paragard IUD). Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose. It is a strong NSAID that is indicated for the treatment of moderate acute pain. In the intramuscular form it has an analgesia onset of action at 30min, thus may be a plausible option for pain management in the office setting compared to oral NSAIDs, which have a longer time to onset of analgesia and have not been proven to be effective in reducing pain associated with IUD placement. The primary aim of this study is to determine whether ketorolac (Toradol) decreases pain associated with intrauterine device placement compared to placebo. We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD insertion when compared to placebo of normal saline injection.
Detailed description
Modern intrauterine devices are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy (Zieman 2010). Fear of intrauterine device placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block compared to paracervical block alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement (Massey 1974). Studies to evaluate effectiveness of motrin and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous (Jensen 1998, Hubacher 2006, Saav 1997). There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed (Oloto 1996).
There have been no studies published to date regarding the use of ketorolac for decreasing pain during and after IUD placement. Ketorolac is an acetic acid NSAID that reversibly inhibits COX 1 and 2, leading to decreased formation of prostaglandin precursors, and is indicated for the use of moderate acute pain in the short term setting. Its administration in the office setting may be good option for providers since intramuscular administration leads to analgesia beginning at 30 minutes, maximal effect 1 to 2 hours after administration, and duration of analgesia approximately 4 to 6 hours for the 30mg intramuscular injection.
Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers at UCSD often suggest certain options. These include ibuprofen at least one hour prior to the procedure, or ibuprofen taken within a few hours after the procedure, or ketorolac injection at least 15-30 minutes prior to the procedure. It would be beneficial for providers to have an evidence based option for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo with 1cc normal saline IM | Placebo comparator | Drug: Normal SalineIf the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route. |
| Toradol, 30mg in 1cc IM | Experimental | Drug: KetorolacIf the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nulliparous and multiparous women ages 18-50, who are English or Spanish speaking, who present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).
Key exclusion criteria (22 listed)
- Pregnancy
- Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
- If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
- Misoprostol administration within 24 hours of enrollment
- History of prior IUD insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: Brand name: toradol, Serial # (01) 1 030409 379649 7Ketorolac 30mg intramuscular injection, 1cc volume | Drug | Toradol, 30mg in 1cc IM |
| Normal SalineAlso: REF# 196604Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection | Drug | Placebo with 1cc normal saline IM |
Primary outcome
VAS (Visual Analogue Scale) Measurement of Pain
Time frame: Pain with IUD placement, measured immediately after placement
The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
4 secondary outcomes
Pain Scores at Other Time Points During and After IUD Placement
Time frame: immediately after each step (see description)
Nulliparous Patients - Subgroup Analysis
Time frame: immediately after each step (see description)
Post-insertion Patient Questionnaire
Time frame: assessed at 15 minutes after IUD insertion
Post-insertion Provider Questionnaire
Time frame: Immediately after IUD placement, on average within 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19588429Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007373. doi: 10.1002/14651858.CD007373.pub2.
- Background: PubMed 22133656Roche NE, Li D, James D, Fechner A, Tilak V. The effect of perioperative ketorolac on pain control in pregnancy termination. Contraception. 2012 Mar;85(3):299-303. doi: 10.1016/j.contraception.2011.10.001. Epub 2011 Nov 30.
- Background: PubMed 21843686Edelman AB, Schaefer E, Olson A, Van Houten L, Bednarek P, Leclair C, Jensen JT. Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women. Contraception. 2011 Sep;84(3):234-9. doi: 10.1016/j.contraception.2011.01.016. Epub 2011 Mar 3.
- Derived from this study: PubMed 26241253Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn L Ngo, MD study director
University of California, San Diego
Sheila Mody, MD MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac and Normal Saline in people with Pain Control With IUD Insertion, run by Lynn Ngo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analogue Scale) Measurement of Pain (time frame: Pain with IUD placement, measured immediately after placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01664559, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.