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This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.
This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen Intravenous | Active Comparator | (group 1) 1 gram IV acetaminophen every 8 hours for three doses |
|
| Acetaminophen Oral | Active Comparator | (group 2) 1 gram oral acetaminophen every 8 hours for three doses |
|
| No acetaminophen | No Intervention | (group 3) no acetaminophen |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen Intravenous | Drug | IV 1 gram f3 doses over 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Postoperative Opiate Consumption | Cumulative opiate consumption (IV morphine equivalents) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Opiate Rescue | Time to first opiate pain medicine requested by patient | 48 hours |
| VAS (Visual Analog Scale) | Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Wilson, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21114616 | Result | Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28. | |
| 21627768 | Result | Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen Intravenous | (group 1) 1 gram IV acetaminophen every 8 hours for three doses Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours |
| FG001 | Acetaminophen Oral | (group 2) 1 gram oral acetaminophen every 8 hours for three doses Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours |
| FG002 | No Acetaminophen | (group 3) no acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen Intravenous | (group 1) 1 gram IV acetaminophen every 8 hours for three doses Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours |
| BG001 | Acetaminophen Oral |
| 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 | Cumulative Postoperative Opiate Consumption | Cumulative opiate consumption (IV morphine equivalents) | Posted | Mean | Full Range | mg | 24 hours |
|
The timeframe for adverse event data was collected up to 48 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen Intravenous | (group 1) 1 gram IV acetaminophen every 8 hours for three doses Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvia Wilson | Medical University of South Carolina | 8437921414 | wilsosh@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2015 | Nov 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen Oral | Drug | Oral 1 gram 3 doses over 24 hours |
|
|
| 24 hours |
| Time Discharge | Time patient meets discharge criteria will be recorded | 24 hours postoperative |
| 21353105 | Result | Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011. |
| 22524979 | Result | Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24. |
| 23220855 | Result | Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6. |
| 17142654 | Result | Alhashemi JA, Alotaibi QA, Mashaat MS, Kaid TM, Mujallid RH, Kaki AM. Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery. Can J Anaesth. 2006 Dec;53(12):1200-6. doi: 10.1007/BF03021581. |
| 23159009 | Result | Wong JY, Carvalho B, Riley ET. Intrathecal morphine 100 and 200 mug for post-cesarean delivery analgesia: a trade-off between analgesic efficacy and side effects. Int J Obstet Anesth. 2013 Jan;22(1):36-41. doi: 10.1016/j.ijoa.2012.09.006. Epub 2012 Nov 15. |
| 23921652 | Result | Singh SI, Rehou S, Marmai KL, Jones APM. The efficacy of 2 doses of epidural morphine for postcesarean delivery analgesia: a randomized noninferiority trial. Anesth Analg. 2013 Sep;117(3):677-685. doi: 10.1213/ANE.0b013e31829cfd21. Epub 2013 Aug 6. |
| 23965210 | Result | Beatty NC, Arendt KW, Niesen AD, Wittwer ED, Jacob AK. Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. J Clin Anesth. 2013 Aug;25(5):379-383. doi: 10.1016/j.jclinane.2013.01.014. Epub 2013 Aug 17. |
| 30561704 | Derived | Wilson SH, Wolf BJ, Robinson SM, Nelson C, Hebbar L. Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial. Pain Med. 2019 Aug 1;20(8):1584-1591. doi: 10.1093/pm/pny253. |
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
| BG002 | No Acetaminophen | (group 3) no acetaminophen |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
(group 3) no acetaminophen
|
|
| Secondary | Time to First Opiate Rescue | Time to first opiate pain medicine requested by patient | Posted | Mean | Standard Error | hours | 48 hours |
|
|
|
| Secondary | VAS (Visual Analog Scale) | Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) . | Posted | Mean | Standard Error | units on a scale | 24 hours |
|
|
|
| Secondary | Time Discharge | Time patient meets discharge criteria will be recorded | Posted | Mean | Standard Deviation | hours | 24 hours postoperative |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Acetaminophen Oral | (group 2) 1 gram oral acetaminophen every 8 hours for three doses Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours | 0 | 47 | 0 | 47 | 0 | 47 |
| EG002 | No Acetaminophen | (group 3) no acetaminophen | 0 | 47 | 0 | 47 | 0 | 47 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |