Post Operative PainPhase 4NCT00385541
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
A Phase 4 study testing Morphine PCA and Hydromorphone PCA in people with Post Operative Pain, run by Columbia University at 1 site in United States.
Trial summary
Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Morphine PCA and Hydromorphone PCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients scheduled for abdominal surgery requiring post-operative PCA
- ASA = I or II
Who cannot join
- preoperative pain or use of pain medication
- narcotic allergy
- morbid obesity (Body Mass Index > 30)
- diagnosis of sleep apnea
- hepatic or renal disease
- use of medications that would affect narcotic pharmacodynamics
- preoperative nausea, vomiting, or pruritis
- diagnosis of alcoholism
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Presbyterian Hospital
New York, New York, 10032
About this study
Official title: The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia
Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug
- Conditions
- Post Operative Pain
- Being tested
- Morphine PCA, Hydromorphone PCA
- Keywords
- pain, morphine, hydromorphone, nausea, vomiting, pruritis
- Medical subject headings
- Pain, Postoperative, Pain, Nausea, Vomiting, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine PCADrug
Also called Astramorph PF, Duramorph, Infumorph
Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL
Hydromorphone PCADrug
Also called Dilaudid
hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes. Receives: Drug: Morphine PCA |
| B | Active comparator | Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes. Receives: Drug: Hydromorphone PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Assessment by Patient
Nausea scale range: (0 = none, 10 = the worst), ordinal.
Measured: 1 hour after surgery, 8 hours after surgery
Secondary outcomes (4)
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).
Measured: 1 hour after surgery, 8 hours after surgery
Pain Assessment by Patient
Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.
Measured: 1 hour after surgery, 8 hours after surgery
The Number of Patients Who Vomited
Measured: 1 hour after surgery, 8 hours after surgery
Mean Score on the Ramsey Scale of Sedation
The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).
Measured: 1 hour after surgery, 8 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startNov 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Flood, Columbia University
- Investigators
- Pamela Flood, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385541
- Sponsor's protocol ID
- AAAA2949
- Status last verified
- Jul 2018
- First submitted
- 5 Oct 2006
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb.
PubMed 18806056
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia
- ClinicalTrials.gov ID
- NCT00385541
- Acronym / sponsor ID
- AAAA2949
- Conditions
- Post Operative Pain
- Keywords
- pain, morphine, hydromorphone, nausea, vomiting, pruritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2003 (actual)
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 Oct 2006 (estimated)
- Results
- Posted 31 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Morphine PCAPatients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes. |
| B | Active comparator | Drug: Hydromorphone PCAPatients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients scheduled for abdominal surgery requiring post-operative PCA
- ASA = I or II
Key exclusion criteria (8 listed)
- preoperative pain or use of pain medication
- narcotic allergy
- morbid obesity (Body Mass Index > 30)
- diagnosis of sleep apnea
- hepatic or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine PCAAlso: Astramorph PF, Duramorph, InfumorphMorphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL | Drug | A |
| Hydromorphone PCAAlso: Dilaudidhydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml | Drug | B |
Primary outcome
Nausea Assessment by Patient
Time frame: 1 hour after surgery, 8 hours after surgery
Nausea scale range: (0 = none, 10 = the worst), ordinal.
4 secondary outcomes
Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
Time frame: 1 hour after surgery, 8 hours after surgery
Pain Assessment by Patient
Time frame: 1 hour after surgery, 8 hours after surgery
The Number of Patients Who Vomited
Time frame: 1 hour after surgery, 8 hours after surgery
Mean Score on the Ramsey Scale of Sedation
Time frame: 1 hour after surgery, 8 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18806056Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Flood, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine PCA and Hydromorphone PCA in people with Post Operative Pain, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea Assessment by Patient (time frame: 1 hour after surgery, 8 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.