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Determine the Clinical Advantage of IV vs PO Acetaminophen

Primary Purpose

Inguinal Hernia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acetaminophen IV Soln

Oral Acetaminophen

Placebo Pills

Saline

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Acetaminophen, Tylenol, Intravenous versus oral

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

ASA scores I-III
Ambulatory surgery patients
Ages 18-75
Surgeries requiring general anesthesia for hernia surgery

Exclusion Criteria:

Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
Known allergy to acetaminophen
Emergency surgery
Patients who were not fasted
Patients who cannot tolerate PO
Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
Pregnancy
Weight less than 50kg
Chronic daily narcotic use
Patients who's anesthetic plan requires regional anesthesia
Patient refusal to participate or do not have capacity to provide consent.

Sites / Locations

Mount Sinai West Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oral Acetaminophen

Acetaminophen IV Soln

Arm Description

Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.

Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.

Outcomes

Primary Outcome Measures

PACU Visual Analogue Pain Scores

Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.

Total MME Intraoperatively

Total Morphine Milligram Equivalent (MME) use intraoperatively

Total Narcotic Use in PACU.

Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)

Secondary Outcome Measures

PACU Length of Stay

Time in PACU

Patient Reported Total Narcotic Use Post-discharge

home opiod use

Patient Satisfaction.

Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction

Full Information

NCT ID

NCT03558555

First Posted

June 4, 2018

Last Updated

January 29, 2020

Sponsor

Yan Lai

1. Study Identification

Unique Protocol Identification Number

NCT03558555

Brief Title

Determine the Clinical Advantage of IV vs PO Acetaminophen

Official Title

Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

December 8, 2017 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yan Lai

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Detailed Description

In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia

Keywords

Acetaminophen, Tylenol, Intravenous versus oral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Acetaminophen

Arm Type

Active Comparator

Arm Description

Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.

Arm Title

Acetaminophen IV Soln

Arm Type

Active Comparator

Arm Description

Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.

Intervention Type

Drug

Intervention Name(s)

Acetaminophen IV Soln

Intervention Description

1000mg of IV acetaminophen

Intervention Type

Drug

Intervention Name(s)

Oral Acetaminophen

Intervention Description

oral acetaminophen 975mg pills

Intervention Type

Drug

Intervention Name(s)

Placebo Pills

Intervention Description

placebo match to acetaminophen

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Intravenous saline

Primary Outcome Measure Information:

Title

PACU Visual Analogue Pain Scores

Description

Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.

Time Frame

baseline, 1 hour, and Day 1 discharge

Title

Total MME Intraoperatively

Description

Total Morphine Milligram Equivalent (MME) use intraoperatively

Time Frame

Day 1

Title

Total Narcotic Use in PACU.

Description

Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

PACU Length of Stay

Description

Time in PACU

Time Frame

up to 24 hours after PACU arrival

Title

Patient Reported Total Narcotic Use Post-discharge

Description

home opiod use

Time Frame

average 7 days

Title

Patient Satisfaction.

Description

Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction

Time Frame

7 days post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA scores I-III Ambulatory surgery patients Ages 18-75 Surgeries requiring general anesthesia for hernia surgery Exclusion Criteria: Patients with contraindications to acetaminophen (history of end organ liver dysfunction) Known allergy to acetaminophen Emergency surgery Patients who were not fasted Patients who cannot tolerate PO Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen Pregnancy Weight less than 50kg Chronic daily narcotic use Patients who's anesthetic plan requires regional anesthesia Patient refusal to participate or do not have capacity to provide consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yan Lai, MD, MPH

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai West Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28742427

Citation

Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.

Results Reference

background

PubMed Identifier

15790675

Citation

Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.

Results Reference

background

PubMed Identifier

29200016

Citation

Olbrecht VA, Ding L, Spruance K, Hossain M, Sadhasivam S, Chidambaran V. Intravenous Acetaminophen Reduces Length of Stay Via Mediation of Postoperative Opioid Consumption After Posterior Spinal Fusion in a Pediatric Cohort. Clin J Pain. 2018 Jul;34(7):593-599. doi: 10.1097/AJP.0000000000000576.

Results Reference

background

PubMed Identifier

31669049

Citation

Patel A, Pai B H P, Diskina D, Reardon B, Lai YH. Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial. J Clin Anesth. 2020 May;61:109628. doi: 10.1016/j.jclinane.2019.109628. Epub 2019 Oct 25.

Results Reference

result

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