NCT02487303

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 5, 2018

Completed
Last Updated

December 5, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

June 25, 2015

Results QC Date

July 30, 2018

Last Update Submit

November 5, 2018

Conditions

Pain, Postoperative

Keywords

AcetaminophenPain, PostoperativeAnalgesia, ObstetricalCesarean Section

Outcome Measures

Primary Outcomes (1)

  • Cumulative Postoperative Opiate Consumption

    Cumulative opiate consumption (IV morphine equivalents)

    24 hours

Secondary Outcomes (3)

  • Time to First Opiate Rescue

    48 hours

  • VAS (Visual Analog Scale)

    24 hours

  • Time Discharge

    24 hours postoperative

Study Arms (3)

Acetaminophen Intravenous

ACTIVE COMPARATOR

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Drug: Acetaminophen Intravenous

Acetaminophen Oral

ACTIVE COMPARATOR

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Drug: Acetaminophen Oral

No acetaminophen

NO INTERVENTION

(group 3) no acetaminophen

Interventions

Acetaminophen IntravenousDRUG

IV 1 gram f3 doses over 24 hours

Also known as: Tylenol
Acetaminophen Intravenous
Acetaminophen OralDRUG

Oral 1 gram 3 doses over 24 hours

Also known as: Tylenol
Acetaminophen Oral

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parturients 18 years
  • Elective Cesarean delivery
  • Spinal anesthesia
  • Able to consent to the study and participate in the follow-up.

You may not qualify if:

  • Weight under 50 kgs
  • Allergy to acetaminophen
  • General anesthesia
  • Urgent or emergent cases
  • Bleeding diathesis or other coagulopathy
  • G6PD deficiency
  • Liver disease
  • Substance abuse or dependence
  • HELLP syndrome
  • Thrombocytopenia or platelet dysfunction
  • History or active gastrointestinal bleeding
  • Acute kidney injury or chronic renal insufficiency
  • Contraindication/refusal to spinal anesthesia
  • Chronic pain
  • Chronic narcotic use
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (10)

  • 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.

    PMID: 21114616RESULT

  • 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.

    PMID: 21627768RESULT

  • 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.

    PMID: 21353105RESULT

  • 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.

    PMID: 22524979RESULT

  • 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.

    PMID: 23220855RESULT

  • 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.

    PMID: 17142654RESULT

  • 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.

    PMID: 23159009RESULT

  • 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.

    PMID: 23921652RESULT

  • 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.

    PMID: 23965210RESULT

  • 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.

    PMID: 30561704DERIVED

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Sylvia Wilson
Organization
Medical University of South Carolina
wilsosh@musc.edu
8437921414

Study Officials

  • Sylvia Wilson, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 1, 2015

Study Start

March 17, 2015

Primary Completion

July 27, 2017

Study Completion

July 27, 2017

Last Updated

December 5, 2018

Results First Posted

December 5, 2018

Record last verified: 2018-11

Locations

US(1)