Phase 2
N=174
Association Between Body Size and Response to Hydromorphone in ED
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01675778 ↗Enrolled (actual)
174
Serious AEs
0.6%
Results posted
Oct 2020
Primary outcome: Primary: Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment — -0.03 correlation coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment |
-0.03 | — |
| PRIMARY Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment |
-0.04 | — |
| SECONDARY Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment |
-0.06 | — |
| SECONDARY Pain Treatment Satisfaction Levels as Assessed by Self-report |
2; 8; 26; 68; 57; 2 | — |
| SECONDARY Number of Participants With Oxygen Saturation Level < 92% |
1 | — |
| SECONDARY Number of Participants With Nausea |
33 | — |
| SECONDARY Effect of Gender on the Correlation Between TBW and Change in Pain Intensity |
0.06; 0.11 | — |
| SECONDARY Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity |
-0.03; 0.08 | — |
| SECONDARY Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity |
5.0; 7.0; 6.0 | — |
| SECONDARY Effects of Age on the Correlation Between TBW and Change in Pain Intensity |
39.5; 42.1; 39.3 | — |
| SECONDARY Number of Participant With Systolic Blood Pressure < 90 mmHg |
— | — |
| SECONDARY Effect of Gender on the Correlation Between BMI and Change in Pain Intensity |
0.0017; 0.1887 | — |
| SECONDARY Number of Participants With Vomit |
4 | — |
| SECONDARY Number of Participants With Skin Itching |
15 | — |
| SECONDARY Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment |
-0.05 | — |
| SECONDARY Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity |
5.0; 5.0; 6.0 | — |
| SECONDARY Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity |
5.0; 6.0; 5.0 | — |
| SECONDARY Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity |
5.0; 5.0; 6.0 | — |
Summary
Pain is the most common complaint for patients presenting to the emergency department (ED). Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and responses to intravenous opioids vary widely and are influenced by multiple factors. The objective of the current study is to examine the association between total body weight, BMI (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.
Eligibility Criteria
Inclusion Criteria
- English or Spanish speaking
- Age 18 - 65 years old
- Acute pain (less than 7 days in duration)
- Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician
Exclusion Criteria
- Allergy to hydromorphone
- Systolic blood pressure < 90 mm Hg
- Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental oxygen
- Alcohol or other drug intoxication as judged by the attending physician
- Suspicion of drug seeking by ED physician
- Use of opioids within the past 24 hours
- Use of a monoamine oxidase inhibitor
- Concurrent use of benzodiazepines
- Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia)
- History of COPD, sleep apnea, renal failure, liver disease
- Pregnancy or breast feeding
- Prior entry of patient in the study
- Inability or unwillingness to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01675778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.