Time of Intravenous Acetaminophen Administration

NCT01699815 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00036568
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.

Conditions

Osteoarthritis

Keywords

acetaminophen; timing; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Changes in Postoperative Pain Scores

  To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain

  preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug

Secondary Outcomes (1)

• Pain Medication Consumption Rates

  Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug

Other Outcomes (1)

• Average Length of Stay (LOS)

  Baseline to discharge (1-4 days)

Study Arms (2)

Preemptive group

ACTIVE COMPARATOR

The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.

Drug: Acetaminophen

Closure group

ACTIVE COMPARATOR

The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Closure group; Preemptive group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Durham Regional Hospital

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Virginia C. Muckler
• Organization: Duke University School of Nursing

chris.muckler@duke.edu

919-684-9307

Study Officials

• Virginia C Muckler, DNP

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 5, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

US (1)