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Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain

A Randomized Clinical Trial Comparing Intravenous Morphine and Intravenous Hydromorphone in the Treatment of Adult ED Patients With Moderate to Severe Pain

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00305058
Enrollment
194
Registered
2006-03-21
Start date
2005-07-31
Completion date
2007-03-31
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

Elderly, Hydromorphone, Morphine, Pain, Acute, Emergency Department

Brief summary

The purpose of this research study is to determine which opiate pain medication (morphine or hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients presenting to the emergency department.

Detailed description

Pain is cited as the most frequent reason for visit to emergency departments (EDs) . It can be estimated from the National Hospital Ambulatory Medical Care Survey, an annual survey of a representative sample of visits to US EDs, that there are 17 million visits per year to US EDs for specific complaints of pain, 29 million visits including back symptoms and injuries not otherwise specified as well as specific mentions of pain. However it is widely acknowledged that pain is seriously under-treated in the ED as well as in other health care settings. The concern regarding under-treatment is reflected in new standards for pain management developed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requiring assessment of pain at triage in the ED and referring to pain measurement as the fifth vital sign. Proper pain management is a tremendous challenge to ED physicians as pain is not only a noxious experience but also a symptom of injury and disease that needs to be understood and appropriately treated. Further complicating pain management is the large interpersonal variability in pain perception and expression reflecting cultural, contextual, and individual differences between people. Reasons for under-treating pain include concern over side effects of opioids, perception of pain complaints as possible drug-seeking behavior, under-staffing, concern that analgesics will mask symptoms, delay early diagnosis, treatment, and contribute to risks of tolerance and dependence in vulnerable patients. The elderly represent a group of patients who may experience pain differently from the non-elderly patient. This growing population has been significantly underrepresented in pain-related studies. Some studies have shown that the elderly are at risk for oligoanalgesia and receive inadequate doses of pain medication. Morphine has long been considered the gold standard in pain control. Hydromorphone is another powerful opiate that has been used extensively for the management of post-operative pain and morphine-resistant cancer-related pain. A recent Cochrane review on the use of hydromorphone found 32 studies that focused on acute pain. Of these 32 studies, only 9 involved intravenous forms of hydromorphone. Of these 8 studies, 5 involved patient controlled analgesia, and only 1 study compared intravenous (IV) hydromorphone to IV morphine. The Cochrane review concludes that there are gaps in the understanding of the efficacy and potency of hydromorphone. Only 1 study of hydromorphone in the ED could be located and this compared IV hydromorphone versus IV meperidine in patients with ureteral colic. Although this study showed hydromorphone was superior at all time periods and had fewer side effects, the study used fixed doses of hydromorphone (1mg) and meperidine (50mg). It has been the clinical experience of some ED physicians that hydromorphone may be a better opiate in patients presenting to the ED with acute pain. Hydromorphone is also the opiate that is usually given if morphine does not adequately control a patient's pain in the ED. Hydromorphone may also have other benefits, such as a faster onset since it is more lipophilic than morphine and crosses the blood-brain barrier faster. If it is shown that hydromorphone gives better pain relief to patients with comparable or fewer side effects when compared with morphine, then we may be able to provide evidence to suggest that hydromorphone should be the parenteral opiate of choice for adult ED patients presenting with acute pain of moderate to severe intensity.

Interventions

DRUGMorphine

0.05 mg/kg Intravenous

DRUGHydromorphone

0.0075 mg/kg intravenous

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age greater than 65 years 2. Pain with onset within 7 days 3. ED attending physician's judgment that patient's pain warrants use of parenteral opioids 4. Normal mental status

Exclusion criteria

1. Prior use of methadone 2. Use of other opioids or tramadol within past seven days 3. Prior adverse reaction to morphine or hydromorphone 4. Chronic pain syndrome 5. Alcohol intoxication 6. Systolic Blood Pressure \<90 mm Hg 7. Use of monoamine oxidase (MAO) inhibitors in past 30 days 8. Elderly patients with a capnometry reading of greater than 46

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain IntensityBaseline to 30 minutes after medication infusedPain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused

Secondary

MeasureTime frameDescription
Number of Participants With a Change in Pain ScoreBaseline to 30 minutes after medication infusedPain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score.
Number of Participants With Pain Relief30 minutes after medication infusedPain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused.
Number of Participants Satisfied With Pain Medication30 minutes after medication infusedNumber of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair.

Countries

United States

Participant flow

Participants by arm

ArmCount
Morphine
0.05 mg/kg IV morphine
90
Hydromorphone
0.0075 mg/kg IV hydromorphone
93
Total183

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyMissing data collection instrument32
Overall StudyMissing outcome data32
Overall StudyParticipant too young10

Baseline characteristics

CharacteristicTotalHydromorphoneMorphine
Age, Continuous75 years
STANDARD_DEVIATION 8
74 years
STANDARD_DEVIATION 8
76 years
STANDARD_DEVIATION 8
Baseline Pain Score
10
86 Participants46 Participants40 Participants
Baseline Pain Score
6
19 Participants10 Participants9 Participants
Baseline Pain Score
7
21 Participants9 Participants12 Participants
Baseline Pain Score
8
38 Participants18 Participants20 Participants
Baseline Pain Score
9
19 Participants10 Participants9 Participants
Number of participants experiencing nausea since pain began
No
96 Participants48 Participants48 Participants
Number of participants experiencing nausea since pain began
Yes
79 Participants38 Participants41 Participants
Number of participants experiencing vomiting since pain began
No
119 Participants60 Participants59 Participants
Number of participants experiencing vomiting since pain began
Yes
59 Participants29 Participants30 Participants
Number of participants who had pain in specific locations
Abdomen/pelvis
101 Participants56 Participants45 Participants
Number of participants who had pain in specific locations
Back
25 Participants7 Participants18 Participants
Number of participants who had pain in specific locations
Chest
6 Participants4 Participants2 Participants
Number of participants who had pain in specific locations
Extremities
13 Participants8 Participants5 Participants
Number of participants who had pain in specific locations
Head/neck
4 Participants2 Participants2 Participants
Number of participants who had pain in specific locations
Other
33 Participants15 Participants18 Participants
Number of participants who had pain in specific locations
Unknown/missing data
1 Participants1 Participants0 Participants
Number of participants who took analgesics before coming to the ED
None
141 Participants75 Participants66 Participants
Number of participants who took analgesics before coming to the ED
Some
42 Participants18 Participants24 Participants
Primary Language
English
102 Participants51 Participants51 Participants
Primary Language
Other
5 Participants0 Participants5 Participants
Primary Language
Spanish
73 Participants40 Participants33 Participants
Primary Language
Unknown
3 Participants2 Participants1 Participants
Race/Ethnicity, Customized
Black
49 Participants28 Participants21 Participants
Race/Ethnicity, Customized
Hispanic
86 Participants47 Participants39 Participants
Race/Ethnicity, Customized
Other
3 Participants0 Participants3 Participants
Race/Ethnicity, Customized
White
45 Participants18 Participants27 Participants
Region of Enrollment
United States
183 Participants93 Participants90 Participants
Sex: Female, Male
Female
128 Participants65 Participants63 Participants
Sex: Female, Male
Male
55 Participants28 Participants27 Participants
Weight153 lbs
STANDARD_DEVIATION 29
157 lbs
STANDARD_DEVIATION 29
148 lbs
STANDARD_DEVIATION 29

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 900 / 93
other
Total, other adverse events
14 / 9023 / 93
serious
Total, serious adverse events
0 / 900 / 93

Outcome results

Primary

Change in Pain Intensity

Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused

Time frame: Baseline to 30 minutes after medication infused

ArmMeasureValue (MEAN)Dispersion
MorphineChange in Pain Intensity3.3 units on a scaleStandard Deviation 2.5
HydromorphoneChange in Pain Intensity3.8 units on a scaleStandard Deviation 2.6
Secondary

Number of Participants Satisfied With Pain Medication

Number of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair.

Time frame: 30 minutes after medication infused

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
MorphineNumber of Participants Satisfied With Pain MedicationGood to excellent56 Participants
MorphineNumber of Participants Satisfied With Pain MedicationPoor to fair34 Participants
HydromorphoneNumber of Participants Satisfied With Pain MedicationGood to excellent59 Participants
HydromorphoneNumber of Participants Satisfied With Pain MedicationPoor to fair34 Participants
Secondary

Number of Participants With a Change in Pain Score

Pain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score.

Time frame: Baseline to 30 minutes after medication infused

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
MorphineNumber of Participants With a Change in Pain Scoreless than 50% decrease53 Participants
MorphineNumber of Participants With a Change in Pain Scoregreater than or equal to 50% decrease37 Participants
HydromorphoneNumber of Participants With a Change in Pain Scoreless than 50% decrease53 Participants
HydromorphoneNumber of Participants With a Change in Pain Scoregreater than or equal to 50% decrease40 Participants
Secondary

Number of Participants With Pain Relief

Pain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused.

Time frame: 30 minutes after medication infused

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
MorphineNumber of Participants With Pain Reliefnone or slight37 Participants
MorphineNumber of Participants With Pain Reliefmoderate to complete53 Participants
HydromorphoneNumber of Participants With Pain Reliefnone or slight32 Participants
HydromorphoneNumber of Participants With Pain Reliefmoderate to complete61 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026