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Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

Primary Purpose

Post Operative Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Morphine PCA

Hydromorphone PCA

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring pain, morphine, hydromorphone, nausea, vomiting, pruritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients scheduled for abdominal surgery requiring post-operative PCA
ASA = I or II

Exclusion Criteria:

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

Sites / Locations

Columbia Presbyterian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.

Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.

Outcomes

Primary Outcome Measures

Nausea Assessment by Patient

Nausea scale range: (0 = none, 10 = the worst), ordinal.

Secondary Outcome Measures

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).

Pain Assessment by Patient

Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.

The Number of Patients Who Vomited

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).

Full Information

NCT ID

NCT00385541

First Posted

October 5, 2006

Last Updated

July 16, 2018

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00385541

Brief Title

Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

Official Title

The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

November 2003 (Actual)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

Keywords

pain, morphine, hydromorphone, nausea, vomiting, pruritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes.

Arm Title

Arm Type

Active Comparator

Arm Description

Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.

Intervention Type

Drug

Intervention Name(s)

Morphine PCA

Other Intervention Name(s)

Astramorph PF, Duramorph, Infumorph

Intervention Description

Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL

Intervention Type

Drug

Intervention Name(s)

Hydromorphone PCA

Other Intervention Name(s)

Dilaudid

Intervention Description

hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Primary Outcome Measure Information:

Title

Nausea Assessment by Patient

Description

Nausea scale range: (0 = none, 10 = the worst), ordinal.

Time Frame

1 hour after surgery, 8 hours after surgery

Secondary Outcome Measure Information:

Title

Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale

Description

The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).

Time Frame

1 hour after surgery, 8 hours after surgery

Title

Pain Assessment by Patient

Description

Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.

Time Frame

1 hour after surgery, 8 hours after surgery

Title

The Number of Patients Who Vomited

Time Frame

1 hour after surgery, 8 hours after surgery

Title

Mean Score on the Ramsey Scale of Sedation

Description

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).

Time Frame

1 hour after surgery, 8 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients scheduled for abdominal surgery requiring post-operative PCA ASA = I or II Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Flood, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia Presbyterian Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18806056

Citation

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.

Results Reference

result

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Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

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