Speed of opioid infusion could change how cancer patients feel pain and drug effects
NCT ID NCT04296305
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving the painkiller hydromorphone slowly or quickly through an IV affects how well it controls cancer pain and how likely it is to be misused. About 84 hospitalized cancer patients with moderate to severe pain will receive both a slow and a fast infusion in random order. The goal is to find the safest and most effective way to give IV opioids for cancer pain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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84 people
The number who actually took part.
- Started
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Sep 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Hospitalized patients with diagnosis of cancer * History of moderate to severe cancer related pain, defined as Numerical Rating Scale (NRS) pain score \>= 4/10 * Receiving no or only on as needed doses of opioids * Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits or a Memorial Delirium Assessment Scale (MDAS) score of \< 13 * Ability to read and communicate in the English language * Written informed consent from patient Exclusion Criteria: * Contraindications to opioids, or history of opioid allergy * Inability to secure IV access * Known history or evidence of nonmedical opioid use (e.g. abuse, misuse, addiction) * Oxygen saturations \< 92% or respiratory rate \< 12 breaths/minute on initial assessment * Resting heart rate \> 120 on initial assessment * Systolic blood pressure \> 180 \< 90 mmHg or diastolic pressure \> 100 \< 60 mmHg on initial assessment * Patients receiving scheduled chronic opioid therapy (defined as the treatment of pain with opioids for \>= 7 days) * Moderate to severe renal insufficiency (defined as glomerular filtration rate \[GFR\] \< 60 ml/min/1.73 m\^2) * Hepatic insufficiency (defined as alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the highest normal value, or total bilirubin \> 1.5 times the highest normal value)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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