NCT02694653

Brief Summary

To evaluate the use of maternal opiates for pain control post cesarean delivery in those patients that received intravenous acetaminophen 1000 mg in 150 mL of normal saline, infused 30 minutes prior to incision compared to placebo. A comparison of post delivery length of stay in both study groups will be evaluated for cost effectiveness of the use of acetaminophen. a secondary purpose is to determine the levels of neonatal acetaminophen in cord blood at the time of delivery, since this has never been studied.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Status
unknown

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

October 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

January 21, 2016

Last Update Submit

April 18, 2017

Conditions

Complications; Cesarean Section

Keywords

C/section, Acetaminophen

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Maximum follow up time for assessment

    Up to 26 months

Secondary Outcomes (2)

  • Milligrams of narcotics given

    Up to 26 months

  • Milligrams of Acetaminophen in cord blood

    At delivery

Study Arms (2)

Drug Arm

ACTIVE COMPARATOR

Acetaminophen 1000 mg in 100 mL normal saline IV administered 30 minutes prior to c/section incision to infuse within 15 minutes

Drug: Acetaminophen

Placebo Arm

PLACEBO COMPARATOR

100 mL normal saline IV administered 30 minutes prior to c/section incision to infuse within 15 minutes

Drug: Placebo

Interventions

PlaceboDRUG

100 mL of normal saline IV given 30 minutes prior to elective c/section incision vs acetaminophen 1000 mg IV

Also known as: Normal Saline
Placebo Arm
AcetaminophenDRUG

1000 mg acetaminophen in 100 mL normal saline IV given 30 minutes prior to elective c/section incision vs placebo

Also known as: Tylenol
Drug Arm

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant having an elective c/section

You may not qualify if:

  • Acetaminophen allergy
  • Hepatitis history
  • Liver or kidney disease
  • Use of Tylenol within 24 hours
  • Use of opiates within 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.

    PMID: 23567482BACKGROUND

  • Tsang KS, Page J, Mackenney P. Can intravenous paracetamol reduce opioid use in preoperative hip fracture patients? Orthopedics. 2013 Feb;36(2 Suppl):20-4. doi: 10.3928/01477447-20130122-53.

    PMID: 23379572BACKGROUND

  • Needleman SM. Safety of rapid intravenous of infusion acetaminophen. Proc (Bayl Univ Med Cent). 2013 Jul;26(3):235-8. doi: 10.1080/08998280.2013.11928969.

    PMID: 23814378BACKGROUND

  • Towers CV, Shelton S, van Nes J, Gregory E, Liske E, Smalley A, Mobley E, Faircloth B, Fortner KB. Preoperative cesarean delivery intravenous acetaminophen treatment for postoperative pain control: a randomized double-blinded placebo control trial. Am J Obstet Gynecol. 2018 Mar;218(3):353.e1-353.e4. doi: 10.1016/j.ajog.2017.12.203. Epub 2017 Dec 21.

    PMID: 29274831DERIVED

MeSH Terms

Interventions

Saline SolutionAcetaminophen

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Craig V. Towers, MD

    University of Tennessee Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean, Graduate School of Medicine

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 29, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Present at national medical conference and publish in medical journal