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Pain Management Interventions for Postpartum Pain
Study Summary
This trial will compare the effects of three different interventions on perineal pain in postpartum women 1 week after sustaining an obstetric anal sphincter injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are carrying a baby that has reached the full term of pregnancy (more than 37 weeks).I am older than 18 years.I will have an epidural for pain relief during delivery.I have had multiple urinary tract infections.I have had surgery in my pelvic area before.I have been diagnosed with obstructive sleep apnea.I had high blood pressure or preeclampsia when I gave birth.I have a history of chronic pain in my pelvic area.
- Group 1: Epidural saline + IV saline
- Group 2: Epidural morphine 3 mg + IV saline
- Group 3: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned the application of Epidural morphine 3 mg + IV ketamine 0.3 mg/kg?
"Due to its Phase 4 status, indicating that Epidural morphine 3 mg + IV ketamine 0.3 mg/kg is approved for medical use, we have allocated a score of 3 indicating it has strong safety ratings."
Is there still an opportunity for prospective participants to join this experiment?
"As per clinicaltrials.gov, this trial is presently in search of participants. It was initially posted on June 27th 2018 and the most recent update came on January 11th 2022."
Could you please describe the results of prior experiments involving Epidural morphine 3 mg + IV ketamine 0.3 mg/kg?
"Presently, 155 clinical trials are assessing the efficacy of Epidural morphine 3 mg + IV ketamine 0.3 mg/kg. Of those studies, 34 have progressed to Phase 3. Although Boston, Massachusetts is at the epicentre of this research area with numerous trials running there, a total of 285 sites across America offer these treatments."
What medical treatments are Epidural morphine 3 mg + IV ketamine 0.3 mg/kg usually employed for?
"Pain, general anaesthesia and induction/maintenance of general anaesthesia can be successfully treated using a combination of epidural morphine (3mg) plus an intravenous dose of ketamine at 0.3 mg/kg."
How many participants are engaging in this trial altogether?
"Affirmative. An examination of clinicaltrials.gov data reveals that this medical study, which was published on June 27th 2018, is actively recruiting patients. 160 volunteers need to be sourced from one particular location."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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