A Comparison of the Safety and Effectiveness of Two Forms of Patient-controlled Pain Medication Used After Scheduled Abdominal or Pelvic Surgery: The Fentanyl Transdermal System Versus the Morphine Intravenous Pump

NCT00266539 | Completed Phase 3

• 1 other identifier: CR004717
• Study Type: interventional
• Target: 506
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare two pain medications delivered by two different forms of patient-controlled pain management systems: the Fentanyl HCl Patient-Controlled Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump. Fentanyl HCl and morphine are narcotic pain relievers. The E-TRANS fentanyl system is a small unit worn on the patient's upper outer arm or chest that uses low-intensity electrical current to deliver fentanyl through the skin and into the patient's bloodstream. The patients studied will be those who have just had scheduled abdominal or pelvic surgery.

Conditions

Pain, Postoperative

Keywords

Postoperative pain; patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Success (defined by a rating of "Excellent" or "Good") at the 24-hour patient global assessment of the method of pain control.

Secondary Outcomes (1)

• Proportion of successes at 48 and 72 hours and at final assessment; mean pain intensity assessment at 24, 48, and 72 hours and at final assessment; mean scores from the Ramsay Sedation Scale.

Interventions

E-TRANS Fentanyl hydrochloride; Morphine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a pre-operative American Society of Anesthesiology Physical Status I, II, or III (Class I are healthy persons less than 80 years of age, Class II are patients over age 80 years of age with mild systemic disease, and Class III are patients with severe and non-incapacitating disease)
• Admitted to the Post-Anesthesia Care Unit after general anesthesia or spinal/epidural anesthesia using short-acting agents
• Having had one of these surgical procedures: small and large bowel resections with anastomosis, colectomy, enterolysis, sigmoidectomy, closure of enteric fistulae, repair of cecal or sigmoid volvulus, lower anterior resection, stoma closure, bariatric surgery, liver resection, splenectomy, gastrectomy, fundoplication, total abdominal hysterectomy, total vaginal hysterectomy, anterior-posterior repair, oophorectomy, or myomectomy and cystectomy
• Awake and breathing spontaneously with a respiratory rate of 8 to 24 breaths per minute and oxygen saturation of 90% or higher (with or without supplemental oxygen)
• Expected to remain hospitalized for at least 24 hours postoperatively

You may not qualify if:

• Patients whose postoperative pain would normally be managed with oral or non-narcotic pain medication
• Who received long-acting intraoperative epidural, spinal anesthesia, or local anesthetics in the surgical area, or who are expected to have postoperative analgesia supplied by a continuous regional technique or patient-controlled epidural analgesia
• Have a history of allergy, hypersensitivity, or tolerance to fentanyl or morphine, have a history of allergy or hypersensitivity to cetylpyridinium chloride or skin adhesives, or have the presence of active skin disease that would interfere with application of the E-TRANS fentanyl system
• Who received steroids within 1 month before surgery or during surgery
• Expected to require intensive care postoperatively or who will probably need additional surgical procedures within 72 hours

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Publications (1)

• Minkowitz HS, Rathmell JP, Vallow S, Gargiulo K, Damaraju CV, Hewitt DJ. Efficacy and safety of the fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) with morphine for pain management following abdominal or pelvic surgery. Pain Med. 2007 Nov-Dec;8(8):657-68. doi: 10.1111/j.1526-4637.2006.00257.x.

  PMID: 18028044 RESULT

Related Links

• Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management after Non-emergent Lower Abdominal or Pelvic Surgery

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Alza Corporation Clinical Trial

  Alza Corporation, DE, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 19, 2005
• Study Start: April 1, 2004
• Study Completion: April 1, 2005
• Last Updated: May 19, 2011

Record last verified: 2010-04