To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.
A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
159
1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
Montefiore Medical Center Moses Division Emergency Department
The Bronx, New York, United States
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline \[e.g. Change = NRS(baseline) - NRS(60 min)\]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.
Time frame: baseline and 60 minutes after medication was infused
Change in Pain Intensity Over Time
Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline \[e.g. Change = NRS(baseline) - NRS(15 min)\]. Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes
Time frame: baseline to 5 min, 15 min, 30 min, and 45 minutes
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