Trial Outcomes & Findings for Association Between Body Size and Response to Hydromorphone in ED (NCT NCT01675778)

NCT ID: NCT01675778

Last Updated: 2020-10-08

Results Overview

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 174 participants
• Primary outcome timeframe: 30 minutes post-treatment
• Results posted on: 2020-10-08

Participant Flow

Participants were patients with acute pain recruited from the Emergency Department at Jacobi Medical Center

Participant milestones

Measure	Hydromorphone Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Overall Study STARTED	174
Overall Study COMPLETED	174
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Association Between Body Size and Response to Hydromorphone in ED

Baseline characteristics by cohort

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	163 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39 year STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	93 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	40 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	8 Participants n=5 Participants
Race/Ethnicity, Customized Others	7 Participants n=5 Participants
Region of Enrollment United States	163 Participants n=5 Participants
Cause of pain Injury	15 Participants n=5 Participants
Cause of pain Noninjury	148 Participants n=5 Participants
Pain duration	1 days n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes post-treatment

Population: 174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment	-0.03 correlation coefficient Interval -0.18 to 0.13

PRIMARY outcome

Timeframe: 30 minutes post-treatment

Population: 174 participants completed the treatment but only 163 participants were included in data analysis. The 11 participants were excluded from the data analysis because 2 had prior opioid use, 2 had chronic pain instead acute pain and 7 did not get measured or weighed by staff as required.

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment	-0.04 correlation coefficient Interval -0.16 to 0.08

SECONDARY outcome

Timeframe: 15 minutes post-treatment

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment	-0.06 correlation coefficient Interval -0.21 to 0.1

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Participant's satisfaction with their treatment were assessed by self-report. After treatment, participants were asked "How satisfied are you with the result of your pain treatment today?" and they were told to pick their satisfaction level from "very dissatisfied," "dissatisfied," "uncertain," "satisfied," and "very satisfied." Participants at each level is reported.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Pain Treatment Satisfaction Levels as Assessed by Self-report Very dissatisfied	2 Participants
Pain Treatment Satisfaction Levels as Assessed by Self-report Dissatisfied	8 Participants
Pain Treatment Satisfaction Levels as Assessed by Self-report Uncertain	26 Participants
Pain Treatment Satisfaction Levels as Assessed by Self-report Satisfied	68 Participants
Pain Treatment Satisfaction Levels as Assessed by Self-report Very satisfied	57 Participants
Pain Treatment Satisfaction Levels as Assessed by Self-report Missing	2 Participants

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Opioids can induce respiratory depression, which could lead to low oxygen saturation level. Prolonged low oxygen saturation level < 92% could cause brain damage. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Number of Participants With Oxygen Saturation Level < 92%	1 Participants

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Opioids can could induce nausea. Number of participants with nausea is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Number of Participants With Nausea	33 Participants

SECONDARY outcome

Timeframe: 30 minutes post-treatment

This study evaluated the effect of gender on the correlation between Total Body Weight (TBW) and change in pain intensity. Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effect of Gender on the Correlation Between TBW and Change in Pain Intensity Female	0.06 correlation coefficient Interval -0.25 to 0.14
Effect of Gender on the Correlation Between TBW and Change in Pain Intensity Male	0.11 correlation coefficient Interval -0.15 to 0.35

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Population: Only Hispanic and African American were analyzed, since these two populations were most common in our study participants (Hispanic 57.1%; African American 24.5%).

This study evaluated the effect of race/ethnicity on the correlation between total body weight (TBW) and change in pain intensity. Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=133 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity Hispanic	-0.03 correlation coefficient Interval -0.17 to 0.24
Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity African American	0.08 correlation coefficient Interval -0.24 to 0.38

SECONDARY outcome

Timeframe: 30 minutes post-treatment

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid receptor (OPRM1, A118G). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The median and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity AA	5.0 score on a scale Interval 3.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity AG	7.0 score on a scale Interval 4.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity GG	6.0 score on a scale Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Age might affect the responses to the hydromorphone treatment. The effects of age on the correlation between total body weight (TBW) and change in pain intensity. The mean of age was compared in TBW tertile groups.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effects of Age on the Correlation Between TBW and Change in Pain Intensity low TBW tertile	39.5 years Standard Deviation 11.0
Effects of Age on the Correlation Between TBW and Change in Pain Intensity medium TBW tertile	42.1 years Standard Deviation 11.0
Effects of Age on the Correlation Between TBW and Change in Pain Intensity high TBW tertile	39.3 years Standard Deviation 14.1

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Opioids can induce low blood pressure. Prolonged low systolic blood pressure < 90 mmHg can cause shock and multi-organ failure. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Number of Participant With Systolic Blood Pressure < 90 mmHg	0 Participants

SECONDARY outcome

Timeframe: 30 minutes post-treatment

This study evaluated the effect of gender on the correlation between body mass index (BMI) and change in pain intensity. Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effect of Gender on the Correlation Between BMI and Change in Pain Intensity Female	0.0017 correlation coefficient Interval -0.193 to 0.197
Effect of Gender on the Correlation Between BMI and Change in Pain Intensity Male	0.1887 correlation coefficient Interval -0.064 to 0.418

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Opioids can induce vomit. Number of participants with vomit is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Number of Participants With Vomit	4 Participants

SECONDARY outcome

Timeframe: 30 minutes post-treatment

Opioids can induce skin itching. Number of participants with skin itching is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Number of Participants With Skin Itching	15 Participants

SECONDARY outcome

Timeframe: 15 minutes post-treatment

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment	-0.05 correlation coefficient Interval -0.21 to 0.1

SECONDARY outcome

Timeframe: 30 minutes post-treatment

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid transporter (ABCB1, C3435T). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity CC	5.0 score on a scale Interval 2.0 to 7.0
Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity CT	5.0 score on a scale Interval 3.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity TT	6.0 score on a scale Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: 30 minutes post-treatment

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving pain sensitivity (COMT, G1947A). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity AA	5.0 score on a scale Interval 2.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity AG	6.0 score on a scale Interval 3.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity GG	5.0 score on a scale Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: 30 minutes post-treatment

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid metabolism (UGT2B7, -G840A). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity AA	5.0 score on a scale Interval 3.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity AG	5.0 score on a scale Interval 3.0 to 8.0
Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity GG	6.0 score on a scale Interval 3.0 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes post-treatment

Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported.

Outcome measures

Measure	Hydromorphone n=163 Participants Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Number of Participants Who Desired for More Analgesics	37 Participants

Adverse Events

Hydromorphone

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hydromorphone n=174 participants at risk Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Respiratory, thoracic and mediastinal disorders Oxygen saturation level < 92%	0.57% 1/174 • Number of events 1 • Adverse events were monitored and recorded till 30 minutes after hydromorphone administration while participants were at the ED. Oxygen saturation was measured by pule oximetry. Blood pressure was measured by blood pressure monitor. Nausea, vomit, and itching were recorded by direct observation.

Other adverse events

Measure	Hydromorphone n=174 participants at risk Every enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone.
Gastrointestinal disorders Nausea	19.0% 33/174 • Number of events 33 • Adverse events were monitored and recorded till 30 minutes after hydromorphone administration while participants were at the ED. Oxygen saturation was measured by pule oximetry. Blood pressure was measured by blood pressure monitor. Nausea, vomit, and itching were recorded by direct observation.
Gastrointestinal disorders Vomit	2.3% 4/174 • Number of events 4 • Adverse events were monitored and recorded till 30 minutes after hydromorphone administration while participants were at the ED. Oxygen saturation was measured by pule oximetry. Blood pressure was measured by blood pressure monitor. Nausea, vomit, and itching were recorded by direct observation.
Skin and subcutaneous tissue disorders Itching	8.6% 15/174 • Number of events 15 • Adverse events were monitored and recorded till 30 minutes after hydromorphone administration while participants were at the ED. Oxygen saturation was measured by pule oximetry. Blood pressure was measured by blood pressure monitor. Nausea, vomit, and itching were recorded by direct observation.

Additional Information

Dr. Shujun Xia

Jacobi Medical Center

Phone: 718-918-5800

Email: shujun.xia@nbhn.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place