Opioids vs. Non-Opioids in the Emergency Department for Acute Extremity Pain

Kayla Peltier, Mercer University College of Pharmacy

It is reported that almost two thirds of patients visiting emergency departments do so for treatment of pain. [1] The National Institute on Drug Abuse reports that each day more than 90 Americans die from an opioid overdose (including prescription pain relievers, heroin, and synthetic opioids). Furthermore, it is reported that 21%-29% of patients who are prescribed opioids for chronic pain misuse them, and 8%-12% of chronic pain patients develop an opioid use disorder. [2]

Therefore, this study aimed to compare the efficacy of various oral analgesics in addition to acetaminophen in an effort to determine if a combination of non-opioid analgesics could be a potential treatment option in the setting of acute extremity pain in the emergency department (ED). [3]

Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department
Design Randomized clinical trial; N= 411
Objective To compare the efficacy of four oral analgesics
Study Groups Ibuprofen 400 mg + Acetaminophen 1,000 mg (I+A; n=101)

Oxycodone 5 mg + Acetaminophen 325 mg (O+A; n= 104)

Hydrocodone 5 mg + Acetaminophen 325 mg (H+A; n= 103)

Codeine 30 mg + Acetaminophen 300 mg (C+A; n= 103)

Methods Inclusion Criteria:

–       21-64 years old

–       Presented to the ED for management of acute extremity pain

–       Clinical indication for radiological imaging

Exclusion Criteria:

–       Past use of methadone

–       Presence of a chronic condition requiring frequent management

–       History of an adverse reaction to any study medications

–       Prior use of opioids within 24 hours of study treatment

–       Prior use of ibuprofen or acetaminophen within 8 hours of study treatment

–       Pregnancy

–       Breastfeeding

–       History of peptic ulcer disease

–       Report of any prior use of recreational narcotics

–       Medical conditions that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen

The study was conducted at two emergency departments (ED) in Bronx, New York. After randomization, all subjects rated their pain immediately before administration of study medications, one hour after administration of study medications, and two hours after administration of study medications. Pain intensity was assessed using an   point Numerical Rating Scale (NRS; 0-10) where 0 indicated no pain and 10 indicated the worst pain possible. Subjects received a single dose of an oral analgesic combination as mentioned above, and those who required additional analgesia received an unblinded 5 mg dose of oral oxycodone, which could be administered at any point during the two hour study period at the discretion of the ED attending physician. All subjects were given three identical, unmarked capsules containing the study medications and small amounts of lactulose to equalize the weights of the capsules.

 

Duration July 2016 – August 2016
Primary Outcome Measure Between-group difference in decline in pain two hours after ingestion
Baseline Characteristics  

  I+A

(n= 101)

O+A

(n= 104)

H+A

(n= 103)

C+A

(n= 103)

Female, no. (%) 54 (54) 50 (48) 51 (50) 44 (43)
Age, mean (SD), y 37 (11) 37 (12) 37 (13) 37 (12)
Diagnosis, no. (%)
  Sprain or strain 64 (63) 66 (64) 59 (57) 67 (65)
  Extremity fracture 21 (21) 23 (22) 21 (20) 24 (23)
  Muscle pain 8 (8) 9 (9) 12 (12) 7 (7)
  Contusion 4 (4) 3 (3) 7 (7) 2 (2)
  Other 4 (4) 3 (3) 4 (4) 3 (3)
Nonpharmacological ED interventions, no. (%)
  Elastic bandage 39 (39) 37 (36) 23 (22) 36 (35)
  Splint 12 (12) 20 (19) 18 (18) 10 (10)
  Cast 10 (10) 14 (14) 6 (6) 11 (11)
  Ice 7 (7) 11 (11) 10 (10) 4 (4)
  Other 11 (11) 5 (5) 15 (15) 16 (16)
Results  

NRS Pain Scores and Decline in Pain Scores by Treatment Group
  NRS Pain Score, Mean (95% CI)a
I+A

(n= 101)

O+A

(n= 104)

H+A

(n= 103)

C+A

(n= 103)

p value
Primary end point: decline in score to 2 h 4.3

(3.6-4.9)

4.4

(3.7-5.0)

3.5

(2.9-4.2)

3.9

(3.2-4.5)

0.53
Baseline score 8.9

(8.5-9.2)

8.7

(8.3-9.0)

8.6

(8.3-9.0)

8.6

(8.2-8.9)

0.47
Score at 1 hour 5.9

(5.3-6.6)

5.5

(4.9-6.2)

6.2

(5.6-6.9)

5.9

(5.2-6.5)

0.25
Score at 2 hours 4.6

(3.9-5.3)

4.3

(3.6-5.0)

5.1

(4.5-5.8)

4.7

(4.0-5.4)

0.13
Decline in score to 1 hour 2.9

(2.4-3.5)

3.1

(2.6-3.7)

2.4

(1.8-3.0)

2.7

(2.1-3.3)

0.13
a Pain intensity was assessed using an 11-point NRS in which a score of 0 indicates no pain and a score of 10 indicates the worst possible pain.
Between-Group Difference in Mean Change in NRS Pain Scores
  Between-Group Difference in Mean Change in NRS Pain Score (99.2% CI)
Comparison From Baseline to 1 h From Baseline to 2 h
I+A vs O+A −0.2 (−1.0 to 0.6) −0.1 (−1.0 to 0.8)
I+A vs H+A 0.5 (−0.3 to 1.3) 0.8 (−0.2 to 1.7)
I+A vs C+A 0.2 (−0.6 to 1.0) 0.4 (−0.6 to 1.3)
O+A vs H+A 0.7 (−0.1 to 1.5) 0.9 (−0.1 to 1.8)
O+A vs C+A 0.4 (−0.4 to 1.2) 0.5 (−0.4 to 1.4)
H+A vs C+A −0.3 (−1.1 to 0.5) −0.4 (−1.3 to 0.6)
p values not provided.
Adverse Events Common Adverse Events: Not assessed
Serious Adverse Events: Not assessed
Percentage that Discontinued due to Adverse Events: Not assessed
Study Author Conclusions Data did not demonstrate statistically significant or clinically important differences in pain reduction at 2 hours for all treatment groups.

The data provided from this study demonstrates that ibuprofen plus acetaminophen may provide similar analgesic effects as opioids plus acetaminophen in certain acute situations. Due to the rising concerns of opioid use (e.g., misuse and addiction potential, potential side effects), it may be reasonable to utilize ibuprofen plus acetaminophen in the setting of acute extremity pain in the emergency department.

References

[1] Hoppe JA, Nelson LS, Perrone J, Weiner SG. Opioid prescribing in a cross section of US emergency departments. Ann Emerg Med. 2015;66(3):253-259.e1.

[2] Opioid Crisis. National Institutes of Health. https://www.drugabuse.gov/drugs-abuse/opioids/ opioid-crisis. Updated June 2017. Accessed November 9, 2017.

[3] Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a single dose of oral opioid and nonopioid analgesics on acute extremity pain in the emergency department: A randomized clinical trial. JAMA. 2017;318(17):1661–1667. doi:10.1001/jama.2017.16190.

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