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Running head: IV TYLENOL USE IN POST OPERATIVE ANALGESIA 1 IV Tylenol Use in Post Operative Analgesia Randall Morris, April Schmidt, Michelle Semmes, Mary Shull & Sara Quainoo N312 Duke University School of Nursing

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Running head: IV TYLENOL USE IN POST OPERATIVE ANALGESIA 1

IV Tylenol Use in Post Operative Analgesia

Randall Morris, April Schmidt, Michelle Semmes, Mary Shull & Sara Quainoo

N312

Duke University School of Nursing

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 2

IV Tylenol Use in Postoperative Analgesia

Introduction

Postoperative pain results in suffering and can lead to multiple physiological and

psychological consequences such as splinting, decreased gastrointestinal mobility, and delayed

ambulation leading to increased length of stay. Multimodal analgesia, utilizing non-opioid

analgesics, is one approach to decrease opioid consumption and improve postoperative analgesia.

The use of multimodal analgesic techniques may result in reduced frequency of opioid-related

adverse effects, more effective postoperative pain relief, diminished opioid consumption, and

increased patient satisfaction (Smith, 2011). Intravenous Tylenol is a safe and tolerable

analgesic with the potential to decrease opioid consumption making it an attractive choice in

postoperative pain management (Groudine & Fossum, 2011). The goal of this research utilization

project is to answer the question, “In adult surgical patients (P), does the use of IV Tylenol (I),

compared to not using IV Tylenol (C), result in less opioid consumption (O) during the first 48

hours of the postoperative period (T)?” (Written by Sara, April, and Michelle, Edited by Mary

and Randall)

Methods

See Appendix A

Analysis

Ten studies were reviewed, and while measurement tools varied, each study showed that

the administration of IV acetaminophen decreased the need for postoperative opioid

consumption in adult surgical patients. A 2011 study examined the use of IV acetaminophen and

its role in decreasing opioid consumption after major orthopedic joint replacement surgery. The

study measured pain intensity differences over 24 hours, and the need for rescue medication.

Pain intensity differences were statistically significant in favor of IV acetaminophen compared

with placebo (Sinatra, et al., 2011). Also in 2011, a randomized double blind, placebo controlled

clinical trial performed in 76 women undergoing abdominal hysterectomy examined the

analgesic effect of preoperative acetaminophen on opioid consumption, pain scores, and side

effects in patients receiving an elective abdominal hysterectomy. The results showed a thirty

percent decrease in hydromorphone consumption in the group that received IV acetaminophen

during general anesthesia (Moon, Lee, Lee, & Moon, 2011). A double-blinded RCT involving

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 3

124 adult female patients undergoing robot-assisted endoscopic thyroidectomies found that the

group which received paracetamol had significantly lower pain scores within the first 24

postoperative hours (Hong, Kim, Chung, Yun, & Kill, 2010). Another RCT, which studied 90

adult female patients undergoing total abdominal hysterectomy, showed pain scores in the first

24 hours of the postoperative period to be significantly less in the two groups receiving

paracetamol than in the placebo group.  Morphine consumption was reduced in the study groups

as well (Arici, Gurbet, Turker, Yavascaoglu, & Sahin, 2009). A double-blind, randomized study

examined 99 patients who were given IV propacetamol 2g or IM morphine 10mg or a placebo

following surgical removal of third molar teeth. The response to propacetamol was faster and

stronger then morphine on first administration and required less rescue opioid medication than

the placebo group (Van Aken, Thys, Veekman, & Buerkle, 2004). A double-blind, randomized

study comparing effectiveness of non-opioid analgesics for postoperative pain in 80 patients

following lumbar microdiscectomy found that VAS pain scores were low in all groups. 

Paracetamol VAS scores were not significantly lower then the scores of those in the placebo

group (Grundmann, Wornle, Biedler, Kreuer, Wrobel, & Wilhelm. 2006). A systematic review

of 16 prospective RCT journal articles, published from 2005 through 2010 in 9 countries,

comparing the effects of IV acetaminophen vs. either an active comparator or placebo in adult

patients that received general, regional, sedation, or local anesthesia modalities, were reviewed

using the Jadad Scale to assess quality of the RCTs. In 12 of 14 of the placebo-controlled RCTs,

it was observed that those receiving IV acetaminophen had improved analgesia (Marcario &

Royal, 2011). Another systematic search of 36 RCTs with a cumulative total of 3896 patients,

assessed efficacy of a single dose of IV paracetamol, with co-administration of opioids, in adult

and child postoperative pain relief and intensity. Secondary endpoint analysis focused on the

mean difference in a decreased intervention effect from opioid usage. Only 6 of 36 studies

described the volume of patients that needed opioid rescue medication. Combined results showed

that those receiving placebo required a mean of 1.3 mg more opioid rescue medication than those

who received IV paracetamol (McNicol, et. al., 2011). A single-blind controlled study was

reviewed which sampled 40 adult patients undergoing complex, major abdominal or pelvic

surgery who were randomly determined to receive either IV paracetamol or placebo in

conjunction with IV meperidine. Outcomes were measured in the first 24 hours of the

postoperative period by meperidine consumption and mean pain scores, resulting in significantly

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 4

less consumption of IV meperidine in the group that received IV paracetamol (Memis, et al.,

2010). Finally, a randomized, double blind, placebo-controlled study, with parallel groups,

studied 76 adult patients undergoing elective tonsillectomy to investigate the efficacy, safety, and

opioid sparing effects of IV paracetamol during the first 24 hours of the postoperative period.

The primary measurement tool was the need for rescue medication (meperidine). Seventy-one

percent of patients who received IV paracetamol did not need meperidine and expressed greater

satisfaction with pain control (Atef & Fawaz, 2008). Based on the reviewed RCTs and

systematic reviews, there is strong evidence to support the hypothesis that the use of IV Tylenol

in adult surgical patients in the first 48-hours of the post operative period reduces the

consumption of opioids, when compared to placebo. (Written by group)

Implementation plan

Based on the review of the literature, there is a strong recommendation for IV

acetaminophen use intraoperatively to decrease opioid consumption. As a result, a practice

change will be implemented at Duke University Medical Center over a six-month period to

include intraoperative administration of 1 gram of IV acetaminophen during the maintenance

phase of anesthesia to adult surgical patients. A change team will be formed and will meet

weekly. The team leader will give a presentation during the first meeting on the research

findings; as well as the onset, peak, duration, adverse effects, contraindications, and benefits of

the drug. During the second weekly change team meeting, a key points sheet will be developed.

Information will be disseminated to the anesthesia staff at grand rounds, which is a weekly

anesthesia staff meeting where evidence-based research is discussed. The key points sheets will

be handed out to those in attendance and emailed to all members of the anesthesia team. Posters

promoting the use of IV acetaminophen will be exhibited near medication stations and in the

anesthesia break room. Weekly updates will be posted with statistics regarding usage and goals

for the next week. The updates will be discussed at weekly change team meetings, as well as

weekly grand rounds. (Written by Michelle and April)

Environment for change

In order to assess the environment for change, during the second week, the change team

will administer a questionnaire to the staff to assess their feelings about the change (see

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 5

Appendix B). The clinical expertise and preferences of the staff will be considered, including

the discussion of an option to administer the IV acetaminophen at a different stage of the

anesthesia process (Moon, Lee, Lee, & Moon, 2011). Acetaminophen is a commonly used drug

for patients of all ages, religions, and cultures; therefore few anticipated cultural or religious

objections are expected. Patients with any level of liver dysfunction, however, will not be

candidates to receive IV acetaminophen intraoperatively during the initial phase of

implementation. Resources for implementing the change will jointly be drawn from the budgets

of the Departments of Anesthesia, Nursing, and Pharmacy. Marketing costs associated with the

change will come from the budget of each department to provide the specialized education for

their own personnel. (Written by Mary)

Change team

A multidisciplinary change team will be created to ensure effective implementation. The

team members will consist of a pharmacist, two anesthesiologists, and two CRNAs. The

pharmacist will ensure that there is an adequate supply of IV acetaminophen at all times.

Anesthesia providers will be the members of the health team administering the IV

acetaminophen. It is critical to gain their support, as well as educate them on the appropriate

dose and timing of administration. The members of this team must be stakeholders within their

departments to ensure critical support of the change. (Sara, Michelle, April and Mary)

Outcomes will be measured on a long-term basis, by the anesthesia review nurse. This

nurse will be trained to assess consumption of IV opioids during the first 48-hours of the

postoperative period (Memis, et al., 2010) as part of the routine chart review. The anesthesia

review nurse will not be a member of the change team to decrease the chance for bias in data

collection. All collected data will be objective data from the patients’ charts related to opioid

administration and pain responses recorded by bedside nurses. These results will be reported in

the weekly grand rounds meeting in order to further support the change implementation. Six

months following the implementation of the IV acetaminophen perioperatively, a second

questionnaire (Appendix C) will be administered to the staff in order to reevaluate their

perspectives of efficacy of the use of IV acetaminophen. The validity and reliability of the

questionnaires will be ensured through anonymous responses. (Written by Mary)

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 6

Change Strategy

Objectives Method/ plan Responsibility Completion Date

Measurable outcomes

Increase availability of IV acetaminophen to the OR setting. Initial goal: availability for 75% of adult surgical cases

CRNA will assess quantity needed. Four weeks prior to implementation date, pharmacy will order an adequate supply of IV acetaminophen and stock this in the OR with current standard drugs

Pharmacist and CRNA team leader

8/24/12 Supply of IV acetaminophen was consistently greater than the quantity needed for 75% of adult surgical cases. There were no IV acetaminophen shortages in the first six months of implementation.

Increase use of IV Tylenol to 50% of cases in which there are no contraindications.

Inform Anesthesia providers of the research findings; as well as the onset, peak, duration, adverse effects, contraindications, and benefits of the drug on patient outcomes.

CRNAs/ Anesthesiologists

12/10/12 A quality improvement form will be provided for every case and the anesthesia provider will document if IV Tylenol has been administered or not. Percentage of usage will be calculated weekly and reports will be provided.

(Written by Sara, edited by group)

Resources/Budget/Timeline

Resources needed for the implementation of the use of IV acetaminophen perioperatively

include the drug itself, administration supplies, education and marketing materials for each

department, costs of labor time for the change team, as well as the staff as they are educated on

the practice change. According to a July 19, 2010 DukeHealth.org video transcript of surgery at

Duke, it was estimated that “more than 30,000 surgeries are performed each year” at Duke

Medical Center (Sowers, 2010). Our change strategy will realize increases in IV Tylenol

availability for 75% of the surgeries performed annually at Duke. Budgeting will occur on a

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 7

quarterly basis at a rate of approximately 5,600 surgeries quarterly with secondary goal to

increase use of IV acetaminophen in up to 50% of surgical cases with no contraindications.

According to a June 2011 University of Utah Hospitals and Clinics Pharmacy Bulletin, the

average wholesale price (AWP) for IV Tylenol “is $309.60 for 100 mL vials in packages of 24,

or $12.90 for each single-use 100 mL vial” (Healthcare Utah, 2011). Staffing costs will be billed

at the discipline specific hourly wage accrual rate to account for the Change Team membership

(Appendix D). The six-month implementation timeline (Appendix E) will allow all departments

adequate time to train their staff and incorporate the practice change into their own practice.

(Written by Randall)

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 8

References

Arici, S., Gurbet, A., Turker, G., Yavascaoglu, B., & Sahin, S. (2009). Preemptive analgesic

effects of intravenous paracetamol in total abdominal hysterectomy. Agri, 21(2), 54-61.

Atef, A., & Fawaz, A. (2008). Intravenous paracetamol is highly effective in pain treatment after

tonsillectomy in adults. European Archives of Otorhinolaryngology, 265(3), 351-355.

Groudine, S., & Fossum, S. (2011). Use of intravenous acetaminophen in the treatment of

postoperative pain. J Perianesth Nurs, 26(2), 74-80.

Grundmann, U., Wornle, C., Biedler, A., Kreuer, S., Wrobel, M., & Wilhelm, W. (2006). The

efficacy of the non-opioid analgesics Parecoxib, Paracetamol, and Metamizol for

postoperative pain relief after lumbar microdiscectomy. Anesthesia and Analgesia, 103,

217-222.

Hong, J. Y., Kim, W. O., Chung, W. Y., Yun, J. S., & Kil, H. K. (2010). Paracetamol reduces

postoperative pain and resuce analgesic demand after robot-assisted endoscopic

thyroidectomy by the transaxillary approach. World J Surg, 34(3), 521-526.

Marcario, A., & Royal, M. (2011). A literature review of randomized clinical trials of

intravenous acetaminophen (Paracetamol) for acute postoperative pain. Pain Practice,

11(3), 290-296.

McNicol, E., Tzortzopoulou, A., Cepeda, M., Francia, M., Farhat, T., & Schumann, R. (2011).

Single -dose intravenous Paracetamol or Propracetamol for prevention or treatment of

postoperative pain: A systematic review and meta-analysis. British Journal of

Anaesthesia, 106(6), 764-765.

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 9

Memis, D., Inal, M., Kavalci, G., Sezer, A., & Sut, N. (2010). Intravenous paracetamol reduced

the use of opioids, extubation time, and opioid-related adverse effects after major surgery

in intensive care unit. Journal of Critical Care, 25(3), 458-462.

Moon, Y. E., Lee, Y. K., Lee, J., & Moon, D. E. (2011). The effects of preoperative intravenous

acetaminophen in patients undergoing abdominal hysterectomy. Arch Gynecol Obstet,

284(6), 1455-1460.

Sinatra, R. S., Jahr, J. S., Reynolds, L., Groudine, S. B., Royal, M. A., Breitmeyer, J. B., &

Viscusi, E. R. (2011). Intravenous acetaminophen for pain after major orthopedic

surgery. Pain Practice.

Smith, H. S. (2011). Perioperative intravenous acetaminophen and NSAIDs. Pain Med, 12(6),

961-981.

Sowers, K. (COO). (2008). Your Surgery at Duke Medicine [Marketing Video]. Video March 17,

2012, posted to dukehealth.org Web site: http://www.dukehealth.org/health_library/

video/your_surgery_at_duke_medicine/article_view

Van Aken, H., Thys, L., Veekman, L., & Buerkle, H. (2004). Assessing analgesia in single and

repeated administrations of propacetamol for postoperative pain: Comparison with

morphine after dental surgery. Anesthesia and Analgesia, 98, 159-165.

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 10

Appendix A: Methods

A search using PubMed, Google Scholar, CINAHL, the National Library of Sciences via

the FDA Biosciences Library, and the website www.ofirmev.com was performed using a

combination of specific search terms to yield free access to full-text meta-analysis and

integrative research reviews. Search terms included: “acetaminophen”; “analgesics, non-

steroidal”; “pain, postoperative management”; “analgesics, non-narcotic”; “anti-inflammatory

agents, non-steroidal”; “IV acetaminophen”; “opioids”; “IV Tylenol”; “placebo”; “reduced

opioid AND postoperative”; “IV Tylenol compared to placebo”; “IV acetaminophen AND

opioids”; and “meta-analysis”. In addition, reference lists from articles retrieved and articles

identified on the www.ofirmev.com website were searched to determine if they satisfied our

PICOT research question. Results were culled by each team member during the search process

based on the presence of the following inclusion criteria: adult surgical patients, IV Tylenol use

as opposed to other routes of administration, measured opioid consumption, and articles less than

10 years old. Articles were excluded if they met the following criteria: non-surgical population,

non-adult population, articles not available in the English language, non-human studies, and

articles not available in full text. Search results yielded less than 25 integrative reviews and very

few meta-analyses that were deemed to include the key elements of our PICOT and inclusion

criteria. Most data relied upon in our analysis included randomized control trials (RCTs). A

review of the meta-analyses available revealed that the authors were not able to pool efficacy

results across the research articles because of uncontrolled variations in the variables including

dosing regimen and primary endpoint pain scores. (Written by Randall, Edited by Group)

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 11

Appendix B: Pre-implementation questionnaire

This questionnaire, related to IV acetaminophen, is to be submitted anonymously to the labeled

box in the OR staff lounge.

1) How often do you administer IV acetaminophen intraoperatively as part of your pain

management regimen?

2) If evidence was presented showing the benefit of using IV acetaminophen, would you be

willing to use it?

3) If not, why not?

4) What are the barriers to using IV acetaminophen?

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 12

Appendix C: Post-implementation Questionnaire This questionnaire, related to IV acetaminophen, is to be submitted anonymously to the labeled

box in the OR staff lounge.

1) How often do you administer IV acetaminophen intraoperatively as part of your pain

management regimen?

2) Do you believe evidence (both published literature and your own experience) is sufficient to

include IV acetaminophen in your practice?

3) If not, why not?

4) What are the barriers to using IV acetaminophen?

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 13

Appendix D: Budget

PROGRAM ITEM FY 2013,

1st Qtr

FY 2013

2nd Qtr

FY2013

3rd Qtr

FY2013

4th Qtr.

EXPENSES:

Personnel costs (salary and benefits at hourly rate) Clinical Pharmacist Anesthesiologist (2) CRNAs (2)

Total Personnel Costs

$1,322.46$3,461.54

$12,047.77

$16,831.77

Duke Medical Center Surgery and Nursing Department Marketing

Activities Posters Flyers

Total Marketing Activities

$200$100

$300

Supplies IV Tylenol for 5,600 Quarterly Surgeries

Total Supplies

$72,240

$72,240

Staff Education 15 minute training for each OR staff member $2,103.36

TOTAL EXPENSES$91,475.13

REVENUE

TOTAL REVENUE $0

(Written by Mary)

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 14

Appendix E: Timeline

Task Completion Date

First weekly change team

meeting: Present evidence to

change team

7/2/12

Second weekly change team

meeting: Development of key

points sheet for anesthesia

staff

7/9/12

Distribution of key points

sheet to staff at grand rounds

7/16/12

Distribution of pre-

implementation

questionnaire

7/13/12

Due: 7/20/12

Pre-implementation

questionnaires reviewed by

change team

7/23/12

Training will be completed by

departments related to

dosage, administration,

timing, etc.

8/17/12

Posters and administration

reminders with published “go

8/20/12

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 15

live” date will be posted in

OR lounge and near

medication sources

Pharmacy will obtain, stock

and barcode IV

acetaminophen for OR use

with supply for 75% of adult

surgical cases

8/24/12

“Go live” date for pilot

implementation

9/3/12

Evaluation of weekly

administration and opioid

consumption data

Weekly: 9/10/12 through

12/10/12

Data collection by anesthesia

review nurse

9/3/12 through 12/10/12

Implementation goal: IV

acetaminophen

administration in at least 50%

of adult surgical cases

12/10/12

Distribution of post-

implementation

questionnaire

12/10/12

Due 12/16/12

Evaluation of post-

implementation

12/17/12

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IV TYLENOL USE IN POST OPERATIVE ANALGESIA 16

questionnaire

Presentation of findings to

OR staff and hospital

administration

12/28/12

Change team meeting to

evaluate process and discuss

need for process

improvements and/or more

widespread implementation

1/7/13

(Written by Mary)