Randomized Clinical Trial of Intravenous Acetaminophen as an Analgesic Adjunct for Older Adults With Acute Severe Pain

Andrew K. Chang, Polly E. Bijur, Ashar Ata, Caron M. Campbell, Scott B. Pearlman, Deborah White, Andrew Chertoff, Andrew J. Restivo, E. John Gallagher

Research output: Contribution to journalArticle

Abstract

Objectives: Older adults are at risk for undertreatment of pain. We examined intravenous (IV) acetaminophen as an analgesic adjunct to IV opioids in the care of older emergency department (ED) patients with acute severe pain. Methods: This was a randomized clinical trial conducted in two EDs in the Bronx, New York. Eligible adults aged 65 years and older with acute severe pain were randomized to 0.5 mg of IV hydromorphone and 1 g of IV acetaminophen or 0.5 mg of IV hydromorphone and 100 mL of normal saline placebo. The primary outcome was the between group difference in improvement of numerical rating scale (NRS) pain scores at 60 minutes. Secondary outcomes were the between-group differences in the proportion of patients who chose to forgo additional pain medications at 60 minutes; the proportion who developed side effects; the proportion who required rescue analgesia; and between-group differences in NRS pain scores at 5, 15, 30, and 45 minutes. Results: Eighty-one patients were allocated to each arm. Eighty patients in the IV acetaminophen arm and 79 patients in the placebo arm had sufficient data for analysis. At 60 minutes, patients in the hydromorphone + IV acetaminophen group improved by 5.7 NRS units while those in the hydromorphone + placebo group improved by 5.2 NRS units, for a difference of 0.6 NRS units (95% confidence interval [CI] = –0.4 to 1.5). A total of 28.7% of patients in the hydromorphone + IV acetaminophen group wanted more analgesia at 60 minutes versus 29.1% in the hydromorphone + placebo group, for a difference of –0.4% (95% CI = –14.3% to 13.5%). These differences were neither clinically nor statistically significant. Safety profiles were similar in both groups. Conclusion: In this randomized clinical trial, the addition of IV acetaminophen to IV hydromorphone as an adjunctive analgesic for acute, severe, pain in older adults provided neither clinically nor statistically superior pain relief when compared to hydromorphone alone within the first hour of treatment.

Original languageEnglish (US)
JournalAcademic Emergency Medicine
DOIs
StateAccepted/In press - Jan 1 2018

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Hydromorphone
Acute Pain
Acetaminophen
Analgesics
Randomized Controlled Trials
Pain
Placebos
Analgesia
Confidence Intervals
Opioid Analgesics
Hospital Emergency Service
Safety

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

@article{0b9016da8f944db88eb5498848d3623e,
title = "Randomized Clinical Trial of Intravenous Acetaminophen as an Analgesic Adjunct for Older Adults With Acute Severe Pain",
abstract = "Objectives: Older adults are at risk for undertreatment of pain. We examined intravenous (IV) acetaminophen as an analgesic adjunct to IV opioids in the care of older emergency department (ED) patients with acute severe pain. Methods: This was a randomized clinical trial conducted in two EDs in the Bronx, New York. Eligible adults aged 65 years and older with acute severe pain were randomized to 0.5 mg of IV hydromorphone and 1 g of IV acetaminophen or 0.5 mg of IV hydromorphone and 100 mL of normal saline placebo. The primary outcome was the between group difference in improvement of numerical rating scale (NRS) pain scores at 60 minutes. Secondary outcomes were the between-group differences in the proportion of patients who chose to forgo additional pain medications at 60 minutes; the proportion who developed side effects; the proportion who required rescue analgesia; and between-group differences in NRS pain scores at 5, 15, 30, and 45 minutes. Results: Eighty-one patients were allocated to each arm. Eighty patients in the IV acetaminophen arm and 79 patients in the placebo arm had sufficient data for analysis. At 60 minutes, patients in the hydromorphone + IV acetaminophen group improved by 5.7 NRS units while those in the hydromorphone + placebo group improved by 5.2 NRS units, for a difference of 0.6 NRS units (95{\%} confidence interval [CI] = –0.4 to 1.5). A total of 28.7{\%} of patients in the hydromorphone + IV acetaminophen group wanted more analgesia at 60 minutes versus 29.1{\%} in the hydromorphone + placebo group, for a difference of –0.4{\%} (95{\%} CI = –14.3{\%} to 13.5{\%}). These differences were neither clinically nor statistically significant. Safety profiles were similar in both groups. Conclusion: In this randomized clinical trial, the addition of IV acetaminophen to IV hydromorphone as an adjunctive analgesic for acute, severe, pain in older adults provided neither clinically nor statistically superior pain relief when compared to hydromorphone alone within the first hour of treatment.",
author = "Chang, {Andrew K.} and Bijur, {Polly E.} and Ashar Ata and Campbell, {Caron M.} and Pearlman, {Scott B.} and Deborah White and Andrew Chertoff and Restivo, {Andrew J.} and Gallagher, {E. John}",
year = "2018",
month = "1",
day = "1",
doi = "10.1111/acem.13556",
language = "English (US)",
journal = "Academic Emergency Medicine",
issn = "1069-6563",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - Randomized Clinical Trial of Intravenous Acetaminophen as an Analgesic Adjunct for Older Adults With Acute Severe Pain

AU - Chang, Andrew K.

AU - Bijur, Polly E.

AU - Ata, Ashar

AU - Campbell, Caron M.

AU - Pearlman, Scott B.

AU - White, Deborah

AU - Chertoff, Andrew

AU - Restivo, Andrew J.

AU - Gallagher, E. John

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objectives: Older adults are at risk for undertreatment of pain. We examined intravenous (IV) acetaminophen as an analgesic adjunct to IV opioids in the care of older emergency department (ED) patients with acute severe pain. Methods: This was a randomized clinical trial conducted in two EDs in the Bronx, New York. Eligible adults aged 65 years and older with acute severe pain were randomized to 0.5 mg of IV hydromorphone and 1 g of IV acetaminophen or 0.5 mg of IV hydromorphone and 100 mL of normal saline placebo. The primary outcome was the between group difference in improvement of numerical rating scale (NRS) pain scores at 60 minutes. Secondary outcomes were the between-group differences in the proportion of patients who chose to forgo additional pain medications at 60 minutes; the proportion who developed side effects; the proportion who required rescue analgesia; and between-group differences in NRS pain scores at 5, 15, 30, and 45 minutes. Results: Eighty-one patients were allocated to each arm. Eighty patients in the IV acetaminophen arm and 79 patients in the placebo arm had sufficient data for analysis. At 60 minutes, patients in the hydromorphone + IV acetaminophen group improved by 5.7 NRS units while those in the hydromorphone + placebo group improved by 5.2 NRS units, for a difference of 0.6 NRS units (95% confidence interval [CI] = –0.4 to 1.5). A total of 28.7% of patients in the hydromorphone + IV acetaminophen group wanted more analgesia at 60 minutes versus 29.1% in the hydromorphone + placebo group, for a difference of –0.4% (95% CI = –14.3% to 13.5%). These differences were neither clinically nor statistically significant. Safety profiles were similar in both groups. Conclusion: In this randomized clinical trial, the addition of IV acetaminophen to IV hydromorphone as an adjunctive analgesic for acute, severe, pain in older adults provided neither clinically nor statistically superior pain relief when compared to hydromorphone alone within the first hour of treatment.

AB - Objectives: Older adults are at risk for undertreatment of pain. We examined intravenous (IV) acetaminophen as an analgesic adjunct to IV opioids in the care of older emergency department (ED) patients with acute severe pain. Methods: This was a randomized clinical trial conducted in two EDs in the Bronx, New York. Eligible adults aged 65 years and older with acute severe pain were randomized to 0.5 mg of IV hydromorphone and 1 g of IV acetaminophen or 0.5 mg of IV hydromorphone and 100 mL of normal saline placebo. The primary outcome was the between group difference in improvement of numerical rating scale (NRS) pain scores at 60 minutes. Secondary outcomes were the between-group differences in the proportion of patients who chose to forgo additional pain medications at 60 minutes; the proportion who developed side effects; the proportion who required rescue analgesia; and between-group differences in NRS pain scores at 5, 15, 30, and 45 minutes. Results: Eighty-one patients were allocated to each arm. Eighty patients in the IV acetaminophen arm and 79 patients in the placebo arm had sufficient data for analysis. At 60 minutes, patients in the hydromorphone + IV acetaminophen group improved by 5.7 NRS units while those in the hydromorphone + placebo group improved by 5.2 NRS units, for a difference of 0.6 NRS units (95% confidence interval [CI] = –0.4 to 1.5). A total of 28.7% of patients in the hydromorphone + IV acetaminophen group wanted more analgesia at 60 minutes versus 29.1% in the hydromorphone + placebo group, for a difference of –0.4% (95% CI = –14.3% to 13.5%). These differences were neither clinically nor statistically significant. Safety profiles were similar in both groups. Conclusion: In this randomized clinical trial, the addition of IV acetaminophen to IV hydromorphone as an adjunctive analgesic for acute, severe, pain in older adults provided neither clinically nor statistically superior pain relief when compared to hydromorphone alone within the first hour of treatment.

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