Abstract studies have examined the efficacy of

 

 

 

 

 

 

 

 

 

Abstract

Pain relief following cesarean delivery is
important and needs to be effective, but also safe. The mother needs to be
mobile in order to care for her new infant. Likewise, she needs to consider the
effects of drugs that may enter her breast milk. Currently, the most commonly
utilized modality for pain management post-cesarean is the systemic
administration of opioids by intravenous therapy (IV) or patient-controlled
analgesia.  Although opioids have proven
to provide effective pain relief, there are also a number of negative effects
associated with such drugs, including nausea and vomiting, constipation,
sedation, and respiratory depression. Recent studies have examined the efficacy
of using a multi-modal approach when exploring options for the pain relief
following cesarean delivery. This study aims to examine the potential role of
IV acetaminophen in balancing pain and reducing the use of opioid drugs to
reduce side effects, increase mobility, and maintain safe and healthy breast
milk for the new infant. Sixty post-cesarean delivery patients given IV
acetaminophen or opioids alone will be observed to determine the ability od IV
acetaminophen to reduce opioid consumption in pain management following
cesarean delivery.

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An
Observational Study on the Effect of Intravenous Acetaminophen on Opioid
Requirements of Post-Cesarean Delivery Patients

Pain
relief following cesarean delivery is important. Pain may interfere with the
mother’s ability to provide the necessary care to her newborn and can
negatively affect their initial interactions following delivery. Pain may also
interfere with her ability to effectively breastfeed. Pain relief needs to be
effective, but also safe. The mother needs to be mobile in order to care for
her new infant. Likewise, she needs to consider the effects of drugs that may
enter her breast milk. According to the American Academy of Pediatrics, the
transfer of drugs and chemicals into human milk can pose potential risks to the
new infant and the safest method of pain relief needs to be executed (Kauffman
& Banner, 1994). Different drugs have longer elimination half-lives in
neonates than in adults and could face dose-related toxicities from such drugs
leaked in the breast milk they are consuming (Gadsden, Hart, & Santos,
2005). Currently, the most commonly utilized modality for pain management
post-cesarean is the systemic administration of opioids by intravenous therapy
(IV) or patient-controlled analgesia. Although opioids have proven to provide
effective pain relief, there are also a number of negative effects associated
with such drugs, including nausea and vomiting, pruritus, constipation,
sedation, and respiratory depression (Viscusi, 2012). Recent studies have
examined the efficacy of using a multi-modal approach when exploring options
for the pain relief following cesarean delivery and have found other options
that may be safer than relying on opioids alone. These methods work by using
different classes of analgesics for different neuronal pathways and receptors,
therefore optimizing their efficacy and requiring fewer doses of each (Kehlet & Dahl, 2003). These methods may reduce side effects, recovery time, and overall
costs. One area of exploration of this approach involves the use of IV
acetaminophen (OFIRMEVTM).

What
follows is a summary of the research regarding the use of IV acetaminophen as a
part of a multi-modal approach regimen for surgical patients. Since there are
few studies specifically exploring post-cesarean IV acetaminophen efficacy on
the reduction of opioid analgesia, the studies being reviewed will pertain to
several different types of injury and surgery, as well as different age groups.
Studies revealing the power of IV acetaminophen in reducing the need for opioid
analgesia draw into question the possibility of a multi-modal approach being
utilized in post-cesarean patients being the safest method of pain management.

Impact
of IV acetaminophen on reducing opioid use and adverse symptoms

            Herring
et. al from the Pharmacy Department at Memorial Regency Hospital in Florida
conducted a study to examine the reduction of opioid use post-hysterectomy
surgery. One hundred women underwent total hysterectomies and participated in
this study. 50 women received only opioids and 50 women received 1000mg IV
acetaminophen every 6 hours in conjunction with opioids. The results concluded
a reduction of opioid usage by 31% in the 1-2 day post-operative phase in the
IV acetaminophen group. This study also reported a reduction in frequency of
respiratory depression, gastrointestinal immotility, cognitive impairment, and
sedation due to the reduction in opioid use for the IV acetaminophen group
(Herring, et.al, 2014).

            A
study examining the effects of IV acetaminophen on postoperative requirements
of morphine in neonates and infants was conducted on 71 patients under 1 year
of age undergoing major non-cardiac surgery. All patients received morphine
prior to the surgery. During the 48 hours post-surgery, patients either
received morphine or IV acetaminophen. The patients receiving the IV
acetaminophen resulted in lower cumulative doses of morphine than the
continuous morphine group. Observations from this study also suggest a lowered
risk of respiratory depression in the IV acetaminophen group (Ceelie, et. al,
2013)

            Eighty
patients staying in the ICU following coronary artery bypass grafting
participated in a randomized study examining the effect of IV acetaminophen on
the reduction of the consumption of opioids, as well as a reduction of side
effects, both without the increase of pain during their stay. The patients
receiving IV acetaminophen received less opioids, concurrent with findings in
the previous studies (Pettersson, Jakobsson, & Owall, 2005). 

            A
team from the Department of Anesthesiology at Yale University School of
Medicine examined one hundred fifty-one patients reporting moderate to severe
pain post-orthopedic surgery to explore efficacy and safety of the use of IV
acetaminophen for pain management.  IV
acetaminophen administered over a 24-hour post-operative period showed
significant (33%) decreases in morphine consumption. Drug adverse events were
also significantly lessened (Sinatra, et. al, 2005).

            There
are several reviews containing studies similar to the aforementioned with
similar findings. One such review conducted by a team at Stanford University
examined 14 placebo studies and concluded that 10 of the 14 studies reported
less opioid consumption with the use of IV acetaminophen over a range of
post-operative pain cases (Macario & Royal, 2010). Another review utilized retrospective review of 109 patients
recovering from orthopedic surgery. These patients were split into two groups,
one of which received IV acetaminophen and the other receiving opioid
treatment. The group receiving IV acetaminophen had significantly faster
discharge times, saving time and money (Pawasauskas, Houlihan, & Kelley,
2013).  

            Although
findings reported in this review of the available literature seem consistent
with reduced opioid usage when using IV acetaminophen as a part of a
multi-modal approach, it cannot be assumed that this will be the case in every
post-operative type of surgery. For example, 36 children and adolescents aged
10-18 years of age were analyzed 24 hours after major spinal surgery. The
children were administered IV acetaminophen or saline at 8-hour intervals
post-surgery. Results showed significantly lower reported pain scores. However,
there was no difference found in oxycodone consumption between the 2 groups
during the 24-hour follow up (Hiller, et. al, 2012). These results indicate
that more research needs to be done to examine specific surgeries, age groups,
and other variables. As previously mentioned, there is little to no research
examining specifically the effect of IV acetaminophen on the consumption of
opioid usage post-cesarean surgery.

Aims
of proposed study

Since
there is such an importance for safe and effective pain relief for women
following cesarean section surgery, this study aims to examine the potential
role of IV acetaminophen in balancing pain and reducing the use opioid drugs to
reduce side effects, increase mobility, and maintain safe and healthy breast
milk for her new infant. Since the multi-modal method utilizing IV
acetaminophen has been and is currently conducted following cesarean section
surgery, this study will be strictly observational and non-invasive. The
control observation for this study will be conducted retroactively on patients
who have not received IV acetaminophen during their pain management after
surgery. It is hypothesized that findings will be consistent with previously
reported results and that IV acetaminophen will reduce the amount of necessary
opioid consumption for effective pain relief.

Methods

Participants

            Participants
will consist of 60 total women, over the age of 18, undergoing cesarean
delivery at Hendricks Regional Health Hospital. The women must be in the
hospital >24 hours.  The women must
not have any allergy/intolerance to acetaminophen, hepatic dysfunction, or be
significant alcohol users (defined as patient reported consumption of more than
3 drinks per day). Patients should also have had <5 children prior to surgery and must not be currently managed for chronic pain. Materials              Charts of patients undergoing cesarean sections over the past year who did not use IV acetaminophen will be needed to analyze data for the control group. Procedure             The researcher will complete the data collection in this study. The CRNA will place the regional block, (spinal or epidural), spinal anesthesia for scheduled cesarean sections and epidural placement for laboring patients that become emergent cesarean sections. Post delivery, each patient receives 5.0mg of morphine IV if spinal was method of anesthesia. The epidural group receives 7.0mg of morphine IV post delivery. These dosage methods are the same for both groups being examined: IV acetaminophen and non-IV acetaminophen. The IV acetaminophen group will be given 1000mg acetaminophen post delivery, followed by a second dosage in 6 hrs and a third dosage 12 hrs after delivery. Assessment Each patient will be evaluated for time between acetaminophen administration and request for additional pain control in the following 24hr period. Data collection will include type of narcotic or non-steroidal anti-inflammatory (NSAID) along with the corresponding hour. This data will allow for assessment of number of request along with dosage and time of administration. The control group or non- acetaminophen retroactive group will be assessed in the same manner to include 24hr of request for pain control with corresponding time. Although not the main point of this study, a look at reduced request for relief of nausea, vomiting, and pruritus will be followed. There are several variables that will need to be accounted for, including: The choice of Anesthesia, spinal or epidural with one dose of narcotic added to the regional performed, patient age, race, ethnicity, patient request for additional pain control and which pain medication was requested or given, such as morphine, dilaudid, hydrocodone, demerol, toradol, and their respective dose/route and time of administration. Data analysis             For the 24 hours post-surgery, each patient will be evaluated and data collected by researcher for each hour post-delivery and IV acetaminophen dosage. The data will include each request for additional pain relief and what medication was delivered. A paired t-test will then be used to compare each patient's request during each hour for 24 hours. All patients in each group will then be compared hourly using an ANOVA test. Conclusion IV acetaminophen was approved by the FDA in November 2010 for the management of moderate to severe pain when used adjunctively with opioid analgesics. The use of IV acetaminophen has grown increasingly attractive for its safety and its tolerability among adults and children. It is not associated with adverse effects and has not shown any clinically significant drug interactions (Groudinen & Fossum, 2011). The drug is reliable, predictable, and can be given before or during surgery to begin pain management proactively. One benefit of using IV acetaminophen could be its reduction in opioid use post-operatively using the multi-modal approach. As stated previously, a safe and effective methods of pain management is required for mothers following delivery in order to be mobile and healthy for their new infant. The importance of this expands beyond care and interaction and into the safety of the mother's breast milk for her new infant. IV acetaminophen may provide the safety and efficacy needed in this circumstance. Although there is some research regarding its efficacy in the reduction of opioids for pain relief, there is little to no research exploring this in post-cesarean delivery patients. It is the intention for this study to add valuable information to the role of IV acetaminophen in post-operative surgery, specifically that of cesarean section, to lessen the gap of effects in surgeries that are still unknown.                                  

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