Acute Pain
Conditions
Keywords
Older adults, Elderly, Acute pain, IV acetaminophen, IV hydromorphone, Analgesia, Adjunctive analgesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV acetaminophen + 0.5 mg IV hydromorphone
1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
DRUGNormal saline + 0.5 mg IV hydromorphone
100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
Sponsors
National Institute on Aging (NIA)
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician
Exclusion criteria
* Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics. * Prior adverse reaction to hydromorphone, morphine, or acetaminophen. * Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. * Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. * Systolic Blood Pressure (SBP) \<100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension. * Heart Rate (HR) \< 60/min: Opioids can cause bradycardia. * Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. * Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. * Patients using transdermal pain patches
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused | baseline and 60 minutes after medication was 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Over Time | baseline to 5 min, 15 min, 30 min, and 45 minutes | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Acetaminophen + 0.5 mg IV Hydromorphone 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone | 80 |
| Placebo + 0.5 mg IV Hydromorphone 100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
Normal saline + 0.5 mg IV hydromorphone: 100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone | 79 |
| Total | 159 |
Baseline characteristics
| Characteristic | Placebo + 0.5 mg IV Hydromorphone | Total | IV Acetaminophen + 0.5 mg IV Hydromorphone |
|---|---|---|---|
| Age, Continuous | 72 years | 72 years | 72 years |
| Baseline Pain intensity 10 | 18 Participants | 35 Participants | 17 Participants |
| Baseline Pain intensity 5-7 | 10 Participants | 23 Participants | 13 Participants |
| Baseline Pain intensity 8 | 24 Participants | 38 Participants | 14 Participants |
| Baseline Pain intensity 9 | 8 Participants | 22 Participants | 14 Participants |
| Number of patients nauseated before receiving study medication No - not nauseated | 41 Participants | 87 Participants | 46 Participants |
| Number of patients nauseated before receiving study medication Yes - Nauseated | 38 Participants | 72 Participants | 34 Participants |
| Number of patients vomited before receiving study medication No - Did not vomit | 61 Participants | 124 Participants | 63 Participants |
| Number of patients vomited before receiving study medication Yes - Vomited | 18 Participants | 35 Participants | 17 Participants |
| Race/Ethnicity, Customized African American | 12 Participants | 32 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 51 Participants | 102 Participants | 51 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 20 Participants | 7 Participants |
| Region of Enrollment United States | 79 participants | 159 participants | 80 participants |
| Sex: Female, Male Female | 31 Participants | 61 Participants | 30 Participants |
| Sex: Female, Male Male | 48 Participants | 98 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 79 |
| other Total, other adverse events | 16 / 80 | 13 / 79 |
| serious Total, serious adverse events | 0 / 80 | 0 / 79 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen + 0.5 mg IV Hydromorphone | Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused | 5.8 units on a scale | Standard Deviation 3.2 |
| Placebo + 0.5 mg IV Hydromorphone | Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused | 5.2 units on a scale | Standard Deviation 3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Acetaminophen + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 5 minutes | 3.4 units on a scale | Standard Deviation 2.8 |
| IV Acetaminophen + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 15 minutes | 4.7 units on a scale | Standard Deviation 3.1 |
| IV Acetaminophen + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 30 minutes | 5.1 units on a scale | Standard Deviation 2.9 |
| IV Acetaminophen + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 45 minutes | 5.5 units on a scale | Standard Deviation 2.9 |
| Placebo + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 45 minutes | 5.2 units on a scale | Standard Deviation 2.8 |
| Placebo + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 5 minutes | 2.9 units on a scale | Standard Deviation 2.4 |
| Placebo + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 30 minutes | 4.8 units on a scale | Standard Deviation 2.6 |
| Placebo + 0.5 mg IV Hydromorphone | Change in Pain Intensity Over Time | Baseline to 15 minutes | 4.0 units on a scale | Standard Deviation 2.6 |