PainNCT00910208

Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

A study testing morphine in people with Pain, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pain
What is being tested?: morphine
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Jun 2010
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients presenting to the ED with a chief complaint of abdominal pain of less than or equal to 7 days duration
Age 18 to 65 years
Patient deemed by the ED attending physician to require IV opioid analgesia

Who cannot join

Current use of prescription or non-prescription opioids
Long-term use of opioids, chronic pain syndrome
Clinician suspicion of opioid dependence/abuse
Clinical suspicion of intoxication
Pregnancy or breast-feeding
History of chronic obstructive pulmonary disease, history of sleep apnea, oxygen saturation < 97%

Show all 12Show fewer

Systolic blood pressure < 100 mm Hg
Use of monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants
History of renal insufficiency/renal failure
Prior allergic reaction to morphine
Inability to provide informed consent
Previous entry of patient into study

Trial locations and contacts

1 site in 1 country.

United States1 site

Jacobi Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Read the detailed description

The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:

PCA with 1.0 mg morphine demand dosing every 6 minutes,
PCA with 1.5 mg demand dosing every 6 minutes and
a non-PCA comparison group.

All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.

We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.

Conditions: Pain
Being tested: Patient-controlled analgesia, morphine
Keywords: Pain, Analgesia, Analgesia, Patient-controlled, Emergency Medicine
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient-controlled analgesiaDevice
Also called PCA
Intravenous morphine delivered via Curlin painsmart PCA device
morphineDrug
Intravenous morphine

Study groups in NCT00910208
Study group	Role	What they receive
Patient-controlled analgesia 1 mg demand dose	Experimental	0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes Receives: Device: Patient-controlled analgesia; Drug: morphine
Patient-controlled analgesia 1.5 mg demand dose	Experimental	0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes Receives: Device: Patient-controlled analgesia; Drug: morphine
Non-Patient-controlled analgesia comparison group	Active comparator	0.1 mg/kg morphine loading dose plus additional analgesia as needed Receives: Drug: morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.
Measured: Baseline and 30 minutes post treatment
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)
Measured: 30 minutes post treatment
Long Term Efficacy: Total Analgesia Provided Over 2 Hours
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain
Total analgesia is measured by a summary of change in pain that varies from 0 - no change to
Measured: Baseline, 30, 60, 90, 120 post-treatment
Long Term Efficacy: Pain Relief by 120 Minutes
Participants aksed to and give range
Measured: 120 minutes
Safety: Incidence of Adverse Events
Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)
Measured: 2 hours

Secondary outcomes (1)

Need for Supplementary Analgesia
count of participants who needed or did not needed additional analgesia
Measured: 2 hours post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2010

First posted29 May 2009 (estimated)
Study startApr 2009
Primary completionJun 2010
Study completionJun 2010

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 PainStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00910208
Sponsor's protocol ID: 2008-448
Other IDs: 1R21NR010929-01
Status last verified: Dec 2019
First submitted: 27 May 2009
Last updated: 27 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Birnbaum A, Schechter C, Tufaro V, Touger R, Gallagher EJ, Bijur P. Efficacy of patient-controlled analgesia for patients with acute abdominal pain in the emergency department: a randomized trial. Acad Emerg Med. 2012 Apr;19(4):370-7. doi: 10.1111/j.1553-2712.2012.01322.x.
PubMed 22506940

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
ClinicalTrials.gov ID: NCT00910208
Acronym / sponsor ID: 2008-448
Conditions: Pain
Keywords: Pain, Analgesia, Analgesia, Patient-controlled, Emergency Medicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Jacobi Medical Center
Study start: Apr 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 29 May 2009 (estimated)
Results: Posted 27 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:

PCA with 1.0 mg morphine demand dosing every 6 minutes,
PCA with 1.5 mg demand dosing every 6 minutes and
a non-PCA comparison group.

All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Patient-controlled analgesia 1 mg demand dose	Experimental	Device: Patient-controlled analgesia, Drug: morphine0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia 1.5 mg demand dose	Experimental	Device: Patient-controlled analgesia, Drug: morphine0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
Non-Patient-controlled analgesia comparison group	Active comparator	Drug: morphine0.1 mg/kg morphine loading dose plus additional analgesia as needed

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients presenting to the ED with a chief complaint of abdominal pain of less than or equal to 7 days duration
Age 18 to 65 years
Patient deemed by the ED attending physician to require IV opioid analgesia

Key exclusion criteria (12 listed)

Current use of prescription or non-prescription opioids
Long-term use of opioids, chronic pain syndrome
Clinician suspicion of opioid dependence/abuse
Clinical suspicion of intoxication
Pregnancy or breast-feeding

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
Patient-controlled analgesiaAlso: PCAIntravenous morphine delivered via Curlin painsmart PCA device	Device	Patient-controlled analgesia 1 mg demand dose, Patient-controlled analgesia 1.5 mg demand dose
morphineIntravenous morphine	Drug	Non-Patient-controlled analgesia comparison group, Patient-controlled analgesia 1 mg demand dose, Patient-controlled analgesia 1.5 mg demand dose

Primary outcome

Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
Time frame: Baseline and 30 minutes post treatment
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
Time frame: 30 minutes post treatment
Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)
Long Term Efficacy: Total Analgesia Provided Over 2 Hours
Time frame: Baseline, 30, 60, 90, 120 post-treatment
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain Total analgesia is measured by a summary of change in pain that varies from 0 - no change to
Long Term Efficacy: Pain Relief by 120 Minutes
Time frame: 120 minutes
Participants aksed to and give range
Safety: Incidence of Adverse Events
Time frame: 2 hours
Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)

1 secondary outcome

Need for Supplementary Analgesia
Time frame: 2 hours post treatment

Results and safety

Results posted to the registry on 27 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PCA 1 mg Demand Dose	69	67
PCA 1.5 mg Demand Dose	72	70
Non-PCA Comparison Group	70	69

Primary outcome: Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale

Time frame: Baseline and 30 minutes post treatment. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	PCA 1 mg Demand Dose n = 67	PCA 1.5 mg Demand Dose n = 70	Non-PCA Comparison Group n = 69
Value	3.8 (3.0 to 4.6)	4.0 (3.3 to 4.6)	3.6 (2.9 to 4.4)

PCA 1 mg Demand Dose vs PCA 1.5 mg Demand Dose vs Non-PCA Comparison Group: p = 0.82, ANOVA

Primary outcome: Participants With Short Term Efficacy: Pain Relief by 30 Minutes

Time frame: 30 minutes post treatment. Count of participants. Unit: Participants

Measure	PCA 1 mg Demand Dose n = 67	PCA 1.5 mg Demand Dose n = 70	Non-PCA Comparison Group n = 69
No relief	4	4	4
Slight relief	14	10	16
Moderate relief	18	20	12
A lot of relief	24	31	25
Complete relief	7	5	12

PCA 1 mg Demand Dose vs PCA 1.5 mg Demand Dose vs Non-PCA Comparison Group: p = 0.47, Chi-squared

Primary outcome: Long Term Efficacy: Total Analgesia Provided Over 2 Hours

Time frame: Baseline, 30, 60, 90, 120 post-treatment. Mean (95% Confidence Interval). Unit: scores on a scale *minutes

Measure	PCA 1 mg Demand Dose n = 67	PCA 1.5 mg Demand Dose n = 70	Non-PCA Comparison Group n = 69
Value	-16.4 (-18.8 to -14.1)	-17.4 (-19.7 to -15.1)	-13.6 (-15.9 to -11.3)

PCA 1 mg Demand Dose vs PCA 1.5 mg Demand Dose vs Non-PCA Comparison Group: p = 0.06, ANOVA

Primary outcome: Long Term Efficacy: Pain Relief by 120 Minutes

Time frame: 120 minutes. Count of participants. Unit: Participants

Measure	PCA 1 mg Demand Dose n = 65	PCA 1.5 mg Demand Dose n = 69	Non-PCA Comparison Group n = 68
No relief	7	6	6
Slight relief	9	5	18
Moderate relief	9	8	13
A lot of relief	22	34	16
Complete relief	18	16	15

PCA 1 mg Demand Dose vs PCA 1.5 mg Demand Dose vs Non-PCA Comparison Group: p = 0.033, Chi-squared

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 8 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCA 1 mg Demand Dose	0 of 67 (0%)	1 of 67 (1.5%)	0 of 67
PCA 1.5 mg Demand Dose	1 of 70 (1.4%)	0 of 70 (0%)	0 of 70
Non-PCA Comparison Group	1 of 69 (1.4%)	0 of 69 (0%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22506940Birnbaum A, Schechter C, Tufaro V, Touger R, Gallagher EJ, Bijur P. Efficacy of patient-controlled analgesia for patients with acute abdominal pain in the emergency department: a randomized trial. Acad Emerg Med. 2012 Apr;19(4):370-7. doi: 10.1111/j.1553-2712.2012.01322.x.

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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.

Adrienne J Birnbaum, MD, MS principal investigator

Jacobi Medical Center, Albert Einstein College of Medicine

Polly E Bijur, PhD principal investigator

Albert Einstein College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing morphine in people with Pain, run by Albert Einstein College of Medicine 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 3 inclusion and 12 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 27 Dec 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2019). 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?

Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale (time frame: Baseline and 30 minutes post treatment). The study lists 5 primary outcomes in all. 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 NCT00910208, 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 27 Dec 2019.