Efficacy of IV Acetaminophen for Pain Management

NCT02028715 | Completed Phase 4 Results

• 1 other identifier: 2013.08.22.F2
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction. The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation. The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.

Conditions

Post-operative Pain

Keywords

IV Acetaminophen; Ofirmev; Post-operative pain

Outcome Measures

Primary Outcomes (1)

• Opioid Rescue - 48 Hours

  Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine

  First 48 hours including pre-operative and intra-operative medications

Secondary Outcomes (6)

• Return of Bowel Function

  Duration of hospital stay (up to 7 days).

• Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge

  At 24 hours 48 hours, and discharge (up to 7 days)

• Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge

  At 24 hours, 48 Hours, and Discharge (up to 7 days)

• Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge

  At 24 hours, 48 Hours, and Discharge (up to 7 days)

• Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge

  At 24 hours, 48 Hours, and Discharge (up to 7 days)

Study Arms (2)

Experimental (Normal Saline)

PLACEBO COMPARATOR

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Drug: Placebo

Experimental (IV Acetaminophen)

ACTIVE COMPARATOR

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Drug: IV acetaminophen

Interventions

Placebo DRUG

Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Also known as: IV Placebo

Experimental (Normal Saline)

IV acetaminophen DRUG

IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Also known as: Ofirmev

Experimental (IV Acetaminophen)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.

You may not qualify if:

• Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
• Patients with baseline CrCl \<30.
• Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
• Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
• Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
• Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
• Patients that have required regular opioid intake for the 7 days preceding surgery.
• NSAIDs within 8 hours of surgery.
• Chronic steroid use with the exception of low-dose inhaled steroid formulations.
• Chronic alcohol or drug abuse.
• Patients currently pregnant.
• Patients unable to provide informed consent.
• Age \>85
• Any physical, medical, and mental condition that would make participation in the study inadvisable.

Sponsors & Collaborators

• Aultman Health Foundation: lead

Study Sites (1)

Aultman Health Foundation

Canton, Ohio, 44720, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Pain perception and tolerance is an individual characteristics that cannot be controlled. Other limitations include small sample size and reliance on participants to complete surveys at prescribed time.

Results Point of Contact

• Title: Director of Research Programs
• Organization: Aultman Hospital

mary.amos@aultman.com

330-363-7274

Study Officials

• Laura K Randolph, DO, MS

  Aultman Health Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 7, 2014
• Study Start: December 24, 2013
• Primary Completion: June 4, 2014
• Study Completion: June 4, 2014
• Last Updated: January 16, 2019
• Results First Posted: December 26, 2018

Record last verified: 2019-01

Locations

US (1)