This trial is testing if a combination of acetaminophen and ibuprofen is more effective than ibuprofen alone in relieving post-operative pain for patients who have had a Cesarean delivery.
- Opioid Use Disorder
- Postoperative Pain
1 Primary · 12 Secondary · Reporting Duration: Day 2 morning (4 am - 10 am)
Awards & Highlights
2 Treatment Groups
Ibuprofen and acetaminophen
1 of 2
Ibuprofen and placebo
1 of 2
144 Total Participants · 2 Treatment Groups
Primary Treatment: Ibuprofen and acetaminophen · Has Placebo Group · Phase 3
Who is running the clinical trial?
Age 18+ · Female Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Bateman, Brian T., Naida M. Cole, Ayumi Maeda, Sara M. Burns, Timothy T. Houle, Krista F. Huybrechts, Caitlin R. Clancy, et al.. 2017. “Patterns of Opioid Prescription and Use After Cesarean Delivery”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002093.
- Chang, Andrew K., Polly E. Bijur, David Esses, Douglas P. Barnaby, and Jesse Baer. 2017. “Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department”. Jama. American Medical Association (AMA). doi:10.1001/jama.2017.16190.
- Bartels, Karsten, Lena M. Mayes, Colleen Dingmann, Kenneth J. Bullard, Christian J. Hopfer, and Ingrid A. Binswanger. 2016. “Opioid Use and Storage Patterns by Patients After Hospital Discharge Following Surgery”. Edited by Michael Costigan. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0147972.
- Prabhu, Malavika, Emily McQuaid-Hanson, Stephanie Hopp, Sara M. Burns, Lisa R. Leffert, Ruth Landau, Julie C. Lauffenburger, Niteesh K. Choudhry, Anjali Kaimal, and Brian T. Bateman. 2017. “A Shared Decision-making Intervention to Guide Opioid Prescribing After Cesarean Delivery”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002094.
- Viteri, Oscar A., Joey A. England, Mesk A. Alrais, Kayla A. Lash, Maria I. Villegas, Olaide A. Ashimi Balogun, Suneet P. Chauhan, and Baha M. Sibai. 2017. “Association of Nonsteroidal Antiinflammatory Drugs and Postpartum Hypertension in Women with Preeclampsia with Severe Features”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002247.
- Osmundson, Sarah S., Leslie A. Schornack, Jennifer L. Grasch, Lisa C. Zuckerwise, Jessica L. Young, and Michael G. Richardson. 2017. “Postdischarge Opioid Use After Cesarean Delivery”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002095.
- Ong, Cliff K. S., Robin A. Seymour, Phillip Lirk, and Alan F. Merry. 2010. “Combining Paracetamol (acetaminophen) with Nonsteroidal Antiinflammatory Drugs”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3181cf9281.
- Skevington, S.M., M. Lotfy, and K.A. O'Connell. 2004. “The World Health Organization's WHOQOL-BREF Quality of Life Assessment: Psychometric Properties and Results of the International Field Trial. A Report from the WHOQOL Group”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1023/b:qure.0000018486.91360.00.
- Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
- Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Serdar Ural 2019. "Management Of Pain After Cesarean Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03929640.
Frequently Asked Questions
What is the most up-to-date information on Ibuprofen and acetaminophen's FDA approval status?
"Both Ibuprofen and acetaminophen have extensive Phase 3 trial data supporting their efficacy and safety, so they each received a score of 3." - Anonymous Online Contributor
How many test subjects are a part of this experiment?
"The clinicaltrials.gov website contains information indicating that this study is currently looking for patients to enroll. This trial was originally posted on 8/5/2019, and the most recent update was on 9/26/2022. A total of 144 patients are needed from 1 location." - Anonymous Online Contributor
For what primary reasons are people taking Ibuprofen and acetaminophen?
"Inflammation of the mucous membranes, excessive discharge of mucus from the nose, and pain in the muscles and bones can all be treated using Ibuprofen and acetaminophen." - Anonymous Online Contributor
Are new participants currently being sought for this experiment?
"From what is available on clinicaltrials.gov, this study is still recruiting patients and seeking new participants. The trial was originally posted on 8/5/2019, with the most recent update being 9/26/2022." - Anonymous Online Contributor
Could you please list other research projects that have studied Ibuprofen and acetaminophen?
"Currently, there are 118 ongoing trials studying the effects of ibuprofen and acetaminophen. Of these active studies, 36 are in Phase 3. Most of the research regarding Ibuprofen and acetaminophen is centred in Pittsburgh, Pennsylvania; however, there are 1037 locations running these types of trials." - Anonymous Online Contributor