Time of Intravenous Acetaminophen Administration

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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 closure group will receive the first dose of one gram of intravenous acetaminophen administered upon onset of skin closure, 2) the preemptive group will receive the first dose of one gram of intravenous acetaminophen administered within 60 minutes prior to incision. Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6 hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to FDA recommendations.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Preemptive group

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Closure group

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Interventions

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Acetaminophen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No