SMFM Papers ajog.

org

Randomized controlled trial of intravenous acetaminophen

for postcesarean delivery pain control
Brie Altenau, MD; Catrina C. Crisp, MD, MSc; C. Ganga Devaiah, MS; Donna S. Lambers, MD

BACKGROUND: Cesarean delivery is a common surgery in the United extracted from the chart. Power calculation determined that 45
States, with 1.3 million performed during 2009.1 Obstetricians must patients per arm were required to detect a 30% reduction in post-
balance the growing concern with opioid abuse, dependence, and side cesarean narcotic requirement with 80% power and a significance level
effects with optimal postoperative pain control. Intravenous acetamino- of P ¼ .05.
phen may represent an additional method to decrease the reliance on RESULTS: A total of 133 patients were consented for the study.
opioid medications and improve postoperative pain following cesarean Twenty-nine were excluded and 104 patients completed the study: 57
delivery. received intravenous acetaminophen and 47 received placebo. There
OBJECTIVE: The objective of the study was to determine whether the were no differences in baseline demographic characteristics including
administration of intravenous acetaminophen following routine scheduled patient age, body mass index, gravidity, parity, race, comorbidities, or
cesarean delivery would decrease the need for narcotic medications to number of prior cesarean deliveries. There were no differences between
control postoperative pain. groups in estimated blood loss or length of stay. The total amount of oral
STUDY DESIGN: This was an institutional review boardeapproved, narcotic medications consumed by patients receiving intravenous
double-blind, placebo-controlled, randomized trial, registered on acetaminophen was significantly reduced when compared with the
clinicaltrials.gov (number 02046382). Women scheduled to undergo placebo group (47 mg vs 65 mg of oxycodone; P ¼ .034). The total
cesarean delivery with regional anesthesia at term were recruited. All amount of ibuprofen used between groups was not different. There was
perioperative and postpartum care was standardized via study order no difference in pain scores between groups before and after study dose
sets. Study patients were given all medications in a standardized manner administration. There was no significant difference in narcotic side ef-
receiving either acetaminophen 1000 mg intravenously or 100 mL saline fects (nausea/emesis, respiratory depression, constipation) in either
(placebo) every 8 hours for 48 hours for a total of 6 doses. The pharmacy study arm.
prepared intravenous acetaminophen and saline in identical adminis- CONCLUSION: Intravenous acetaminophen in the postoperative
tration bags labeled study drug to ensure blinding. The initial dose of period following cesarean delivery resulted in a significant decrease in oral
study drug was given within 60 minutes of skin incision. Quantity of narcotic consumption for pain control.
breakthrough and scheduled analgesic medications and self-reported
pain levels on the Faces Pain Scale (0e10) before and after study Key words: cesarean delivery, intravenous acetaminophen, multimodal,
drug administration were collected. Patient demographics were pain control, narcotics

C esarean delivery is a common ma-

jor inpatient surgery in the United
States,1 and as such, optimal post-
The American College of Obstetri-
cians and Gynecologists guidelines
recommend that an aim of postoperative
analgesia has been studied and inte-
grated into multiple medical specialties.
The traditional dosing regimen for IV
procedural analgesia is of significant pain management should be to mini- acetaminophen is comparable with the
importance. Per the Centers for Disease mize the amount of narcotics utilized.5 oral route, 1 g every 6 hours for a
Control and Prevention’s evaluation, Multimodal pain management, using maximum dose of 4 g over 24 hours.
many patients become addicted to nar- multiple medications with different Comparative studies between IV and
cotics through the treatment of acute mechanisms of action, is a means by oral administration have demonstrated
pain.2 The use of opioid medications in which to accomplish this goal.6 Research decreased narcotic consumption for the IV
the postoperative setting is many has revealed the importance of this route when used to manage acute pain.8
women’s first exposure to narcotics.3 approach in both the pre- and post- According to the Cochrane Review, effi-
Poorly controlled pain in this setting operative settings for optimal symp- cacy comparisons between IV acetamino-
can be predictive of persistent pain in the tomatic relief of surgical pain.6,7 phen and NSAIDs have demonstrated no
postpartum period.4 Currently in the United States, this is significant difference between the 2 anal-
applied to cesarean delivery pain man- gesics; however, IV acetaminophen does
agement with the use of regional anes- not interfere with platelet function.9
Cite this article as: Altenau B, Crisp CC, Devaiah CG, thesia and a combination of Currently the use of IV acetaminophen
et al. Randomized controlled trial of intravenous acet- intramuscular, intravenous (IV), and in the field of obstetrics for the manage-
aminophen for postcesarean delivery pain control. Am J oral nonsteroidal antiinflammatory ment of postcesarean delivery pain has
Obstet Gynecol 2017;217:362.e1-6.
drugs (NSAIDs), oral acetaminophen, been evaluated only in Saudi Arabia,
0002-9378/$36.00 and IV and oral narcotic medications. Turkey, and Pakistan.10-15
ª 2017 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ajog.2017.04.030
The use of IV acetaminophen as an The hypothesis of this study is that the
effective component of multimodal administration of IV acetaminophen at

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the time of cesarean delivery through 48 drug because Ofirmev (Cadence Phar- pain scores, and the dosage of medica-
hours postoperatively will reduce the maceuticals, San Diego, CA) is normally tion were recorded for all doses of oxy-
amount of narcotics consumed. Sec- packaged in a glass bottle. The dose of codone, ibuprofen, IV narcotics, and the
ondary outcomes included evaluation of the administered drug was 100 mL of study drug.
patient-reported incidence of side effects 1000 mg IVacetaminophen or 100 mL of Postoperative care medications that
and self-reported pain scores. normal saline. Pre- and postoperative are frequently used to treat associated
order sets were developed and utilized side effects of narcotic medications, such
Materials and Methods for this study. This ensured that the pa- as antiemetics and stool softeners, were
This was a randomized, double-blind, tient would not receive any additional also recorded. Additionally, duration of
placebo-controlled trial that was insti- acetaminophen during the study and to hospital stay from admission to
tutional review board approved and standardize all of their perioperative and discharge was collected. Upon discharge
registered on clinicaltrials.gov (National postoperative care. to home, the participant’s chart was
Clinical Trials number 02046382). The The study drug was administered reviewed and the data were abstracted.
Consolidated Standards of Reporting preoperatively within 30e60 minutes
Trials guidelines were followed in the of skin incision. Participants would Analysis
conduct of this study.16 then receive nurse-administered IV A power calculation was completed us-
doses every 8 hours for a total of 6 ing R statistical software, version 2.15.3,
Study participants doses, spanning 48 hours, to keep in and extension packages sample sizes18
The trial was carried out at a large aca- accordance with institution- and epiR.19 Based on previous data,20 a
demic referral center. Enrollment recommended daily dosing of acet- 30% reduction from 71 mg to 50 mg in
occurred from March 2014 to April 2016. aminophen of 3 g. the total postoperative oxycodone con-
Patients scheduled for a cesarean delivery Prior to the study drug infusion, sumption in the placebo group
at gestations of 37 weeks or longer were nursing staff would routinely ask the compared with the IV acetaminophen
screened by research nurses for eligibility. patient to rate their pain, based on the group was considered to be clinically
These patients were approached and revised Faces Pain Scale,17 which is significant. Using the 2-group Student t
written informed consent was obtained. posted in all patient rooms. The test of equal means, 45 patients per study
Subjects were eligible for enrollment if nurses would then record this in the arm would be required to detect the 30%
they met the following inclusion criteria: patient’s electronic medical records reduction with 80% power and a signif-
maternal age of 18 years or greater, EPIC (EPIC, Verona, WI). The Faces icance level of P ¼ .05.
singleton pregnancy, planned regional Pain Scale is a graphical depiction of To account for patients who withdraw
anesthesia with intrathecal morphine sul- pain expressed facially to help patients from the study or who needed to be
fate (Duramorph [Baxter Healthcare convey the intensity of their perceived excluded after consent because of med-
Corp, Deerfield, IL]), and pfannenstiel pain on a scale from 0 to 10, with 10 ical exclusion such as spontaneous labor,
skin incision. correlating with the worst pain they nonscheduled cesarean delivery, pre-
Exclusion criteria included the could be experiencing. eclampsia, and positive drug screen, 50
following variables: body weight less than In addition to the study drug, there per arm or 100 total patients were to be
50 kg, fetal anomalies, documented allergy was a multimodal approach to post- enrolled. A randomization schedule was
to drugs used in the trial, inability to use operative pain control. Breakthrough created using block randomization with
Duramorph at the time of the procedure, medications included IV and oral 10 blocks of 10 participants allocating
positive urine drug screen, opioid addic- narcotics and ibuprofen. For patients randomization numbers to drug or pla-
tion or chronic opiate use, presence of who reported mild to moderate pain, cebo. The numbers were sequentially
hepatic dysfunction (hepatitis, HELLP oral ibuprofen up to 800 mg as needed assigned to participants on the day of
[hemolysis, elevated liver enzymes, and was administered every 8 hours. For their surgery by the pharmacist on duty.
low platelet count], preeclampsia), or the patients who reported moderate to The hospital pharmacy maintained the
development of a postcesarean complica- severe pain, oral oxycodone 5e10 mg master list of the randomization log with
tion including but not limited to post- as needed was administered every 4 patient study identifiers.
partum hemorrhage and preeclampsia. In hours. Continuous variables satisfying the
the circumstance of a postpartum Prior to and after any administration assumption of normality were tested
complication, continuation of the study of analgesic medication, nurses would using the Student t test and means and
drug was dependent on the patient’s status have the patient rate their pain and re- SDs were reported; otherwise, they were
and the type of complication. cord it in the electronic medical records. tested using the Mann-Whitney U test
If the patient’s pain was not controlled by and were accordingly reported using
Study drug preparation these modalities, the physician in charge medians and interquartile ranges. The c2
For the purposes of blinding, IV acet- could prescribe IV narcotic medications or Fisher exact test was utilized to test
aminophen and placebo were packaged such as morphine or hydromorphone categorical variables and sample sizes
in identical IV bags and labeled as study when necessary. Time of administration, and percentages were reported. All

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statistics were analyzed using SPSS sta-

FIGURE
tistical software (version 22.0; SPSS Inc,
CONSORT flow chart of patients randomized in the study
Armonk, NY).
n = 479
Results Paents screened
A total of 133 patients were consented
between March 2014 and April 2016. Enrollment n =346 screen failures
The Figure outlines the recruitment,
enrollment, randomization, and analysis n = 133
Paents consented
of these patients. A total of 104 patients
completed the study, with 57 patients in
n =1 never randomized
the IV acetaminophen arm and 47 pa- Allocaon

tients in the placebo arm.

There were no differences in patient n = 65 n = 67
demographics including patient age, Randomized to Randomized to
IV Acetaminophen Placebo
body mass index at delivery, gravidity, Follow-up

parity, race, recorded comorbidities, or

number of prior cesarean deliveries n =8 Cases excluded. n =20 Cases excluded.
(Table 1). Gestational age at the time of (n = 2) withdrew, (n = 3) withdrew,
cesarean delivery was 39 weeks for both (n = 1) medical exclusion, n =104 (n=2) medical exclusion,
(n = 3) protocol deviaon, (n = 4) protocol deviaon,
Paent data ulized in the
groups. Estimated blood loss for cesar- (n = 2) posive drug screen stascal analysis (n = 7) delivered prior to
ean delivery and total length of stay were the 37 weeks cutoff,
(n = 4) posive drug
equal between the study arms. screen
The primary outcome of this study
was the amount of narcotic pain medi-
cations consumed postoperatively. A
significant decrease in the quantity of
n = 57 n = 47
postoperative narcotics was demon- Randomized to Randomized to
Analysis
strated in the IV acetaminophen study IV Acetaminophen Placebo
arm (Table 2). The IV acetaminophen CONSORT, Consolidated Standards of Reporting Trials.
study arm received an average total of 47 Altenau et al. RCT of IV acetaminophen for cesarean delivery. Am J Obstet Gynecol 2017.
mg of oxycodone during the hospitali-
zation while the placebo group received a
total of 65 mg of oxycodone (P ¼ .034).
Although not statistically significant, Comment difference in pain with 80% power and a
it was also noted that the amount of IV acetaminophen is an effective addi- significance level of P ¼ .05. Hence, the
overall breakthrough medications (19 vs tion to multimodal analgesia in post- 104 total randomized patients also gave
21) and the total amount of ibuprofen cesarean patients by reducing the the study adequate power required to
(4786 vs 5260 mg) used in the IV acet- amount of oral narcotic medications detect a clinically relevant difference in
aminophen study arm were also less than needed to manage surgical pain when pain scores between groups.
placebo. Total amounts of IV morphine, compared with the current multimodal The time frame for recording the
fentanyl, and ketorolac (IV and intra- standard practice at our institution. poststudy drug Faces Pain Scale score
muscular) were also equal between study A secondary aim of our study was to was between 20 minutes and 3 hours.
arms. determine whether IV acetaminophen Taking this into consideration, the
Patient-reported pain scores prior to reduced the perceived pain experienced inability of this study to demonstrate a
and after administration of the study by patients in this setting. Despite a sig- significant change in patient-perceived
drug in both the IV acetaminophen and nificant reduction in narcotic medica- pain between study arms may be due to
placebo groups were not different as tion required for breakthrough pain, the range of time during which the
outlined in Table 3. In both arms, the patients in the IV acetaminophen arm poststudy drug pain scores were ob-
pain scores overall were low, with the did not report improved pain in their tained. Modifying the protocol to
median pain scores between 0 and 4. pain scores before and after their study schedule specific postinfusion pain scale
No differences in adverse events or drug doses. scoring time frames would allow for
side effects from narcotics were noted A clinically relevant change in the better evaluation in this study.
between the groups based on the use of 0e10 pain rating scale has been listed as Prior studies by Omar and Issa12 and
medications that are proxies for the side 2 points.21 A total of 66 total patients Prasanna and Sharma7 have demon-
effects (data not shown). would be required to detect a 2 point strated significant reduction in pain

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TABLE 1
Maternal demographic and clinical characteristics
IV acetaminophen (n ¼ 57) Placebo (saline) (n ¼ 47)
Characteristics Mean (SD) P valuea
Age, y 29.6 (6.0) 29.6 (6.1) .999
Median (IQR)
2
BMI at delivery, kg/m 32.9 (27.3e37.1)b 32.7 (29.3e35.4)b .793
Gravidity 3 (2e4) 3 (2e5) .230
Parity 2 (2e3) 2 (2e3) .445
Gestational age, wks 39.0 (39.0e39.3) 39.1 (38.7e39.3) .830
Estimated blood loss, mL 800 (800e1000)c 800 (800e1000)d .132
Length of stay, h 78 (74e95) 78 (75e98) .855
Number of prior cesarean deliveries 1 (1e1) 1 (1e2) .699
n, %
Race .781
White 33 (57.9) 27 (57.4)
African American 21 (36.8) 19 (40.4)
Multiracial 2 (3.5) 1 (2.1)
Other 1 (1.8) 0 (0)
Gestational diabetes 1 (1.8) 3 (6.4) .326
Smoker 7 (12.3) 4 (8.5) .750
BMI, body mass index; IQR, interquartile range.
a
Computed using the Student t test, Mann-Whitney U test, c2 test, or Fisher exact test; b Denotes 1 missing observation; c Denotes 2 missing observations; d Denotes 4 missing observations.
Altenau et al. RCT of IV acetaminophen for cesarean delivery. Am J Obstet Gynecol 2017.

scores between the IV acetaminophen side effects (ie, pruritus) of regional delivery includes the use of regional
group when compared with placebo at anesthesia. These proxy medications anesthesia with a combination of IV
all time points, yet Alhashemi et al10 could be a poor system for side effects and oral medications such as NSAIDs
showed no appreciable difference be- evaluation, and the use of nurse- and opioids for breakthrough pain.
tween the study arms. documented events requiring inter- Acetaminophen has been included in
Another aim of this study was to vention would be an improved this regimen. As an oral medication, it
determine whether the addition of IV approach in future studies. is subject to the first-pass effect from
acetaminophen to the postcesarean The strengths of this study include the gastrointestinal tract and hence
multimodal analgesic regimen would its design as a double-blinded, ran- takes time to achieve appreciable sys-
decrease the side effects frequently domized controlled trial and that the temic levels.
seen with narcotic use.22 Although pre- and postoperative care was all Following major intraabdominal sur-
narcotic usage in the study arm standardized. Limitations of this study gery such as the cesarean delivery, the
was decreased, there were no appre- include the use of medications as a gastrointestinal tract can be slow to
ciable differences between study arms proxy for narcotic side effects and resume normal activity, and subse-
related to narcotic use based adverse the inability to routinely collect post- quently there is reduced uptake of oral
events. study drug administration patient acetaminophen, diminishing its effec-
To evaluate this outcome, adminis- pain scores at consistent time tiveness.23 The parenteral form is not
tration of medications to correct for intervals. reliant on this metabolism and is able to
narcotic side effects were used as a Research has established the effec- quickly attain therapeutic levels in the
surrogate for these adverse events. The tiveness of a multimodal approach to plasma and subsequently the cerebral
administration of these proxy medi- postoperative pain to achieve superior spinal fluid in which it has its mecha-
cations were predominantly part of analgesia while diminishing reliance nism of action for pain relief compared
routine postprocedural prophylactic on narcotic medications. Current with NSAIDs, which work locally at the
care or for the improvement of the practice for patients after cesarean site of pain.24 We believe this favorable

SEPTEMBER 2017 American Journal of Obstetrics & Gynecology 362.e4

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TABLE 2
Comparison of breakthrough pain medications during inpatient stay
IV acetaminophen (n ¼ 57) Placebo (saline) (n ¼ 47)
Pain medications Mean (SD) P valuea
b
Total oxycodone, mg 47.0 (39.1) 65.0 (46.2) .034c
Total number of breakthrough Medications 19 (7) 21 (7) .133
Total ibuprofen, mg 4786 (2333) 5260 (1915) .267
Median (IQR)
Total morphine, mg 5.0 (5.0e5.0) 5.0 (5.0e5.0) .168
Total fentanyl, mcg 100.0 (0.0e100.0) 100.0 (0.0e100.0) .214
Total ketorolac, mg 30.0 (30.0e60.0) 30.0 (30.0e60.0) .723
d
Total nalbuphine, mg 0.0 (0.0e20.0) 0.0 (0.0e10.0) .918
IQR, interquartile range.
a
Computed using the Student t or Mann-Whitney U test; b Does not include amount of oxycodone in Percocet if patient received Percocet; c Statistically significant at the .05 alpha level; d Denotes 1
missing observation.
Altenau et al. RCT of IV acetaminophen for cesarean delivery. Am J Obstet Gynecol 2017.

pharmacokinetic profile allows for IV studies have demonstrated reduced hours. Despite using less frequent
acetaminophen’s improved palliative ef- requirements for rescue medications dosing, our study was able to
fects in the cesarean delivery setting, such as narcotics, with the adminis- demonstrate similar reductions in oral
allowing patients to achieve adequate tration of IV acetaminophen.6,8,9 Its narcotics medications required for
anesthesia while pursing more pressing incorporation into postcesarean pain recovery analgesia. This trial was un-
matters such as caring and bonding with management has revealed mixed re- able to establish an improvement in
their newborn. sults in patient-perceived pain, with patient-perceived pain by visual
Studies evaluating the use of IV trials revealing either no difference or analog scale because of limitations in
acetaminophen have been limited significantly reduced visual analog design.
with diverse protocols. Currently a scale scores.6-8 In this randomized, placebo-
meta-analysis has failed to demon- These randomized controlled trials controlled, double-blinded trial, IV
strate superiority between opioids, have used the dosing regimen of 1 g of acetaminophen was evaluated for its
NSAIDs, or IV acetaminophen for IV acetaminophen administered every effectiveness as a component in
postcesarean pain relief.9 Multiple 6 hours for a duration of 24e48 multimodal pain management,

TABLE 3
Pain score comparison prior to and after each dose of study drug/ placebo
IV acetaminophen (n ¼ 57) Placebo (saline) (n ¼ 47)
Median (IQR) P valuea
Doses Before After Before After Before After
b c b c
Dose 1 0 (0e0) 0 (0e0) 0 (0e0) 0 (0e0) .839 .678
b c
Dose 2 2 (0e3) 1 (0e2) 0 (0e3) 0 (0e3) .259 .996
Dose 3 1 (0e3) 0 (0e4)b 3 (0e4) 2 (0e5)c .051 .080
b c
Dose 4 2 (1e5) 2 (0e4) 3 (1e6) 3 (0e5) .494 .425
c b c b
Dose 5 3 (2e5) 2 (1e5) 4 (2e5) 3 (2e5) .779 .280
c d b b
Dose 6 3 (2e5) 3 (2e5) 3 (2e5) 4 (2e5) .828 .589
IQR, interquartile range.
a
Computed using the Mann-Whitney U test; b Denotes 8-14 missing observations; c Denotes 2-7 missing observations; d Denotes 21 missing observations.
Altenau et al. RCT of IV acetaminophen for cesarean delivery. Am J Obstet Gynecol 2017.

362.e5 American Journal of Obstetrics & Gynecology SEPTEMBER 2017

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Acknowledgment
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RN (TriHealth Hospitals, Cincinnati, OH), for J Anaesth 2006;53:1200-6. 21. Farrar JT, Berlin JA, Strom BL. Clinically
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SEPTEMBER 2017 American Journal of Obstetrics & Gynecology 362.e6