Clinical Trial: Naloxone for the Treatment of Opioid-Induced Pruritus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Naloxone for the Treatment of Opioid-Induced Pruritus: A Double-Blind, Prospective, Randomized, Controlled Study

Brief Summary:

The purpose of this study is to improve how we treat itching, a common side effect associated with the use of morphine pain medication. Itching is a problem experienced by up to 30% of the children treated with pain medications in the morphine family.

Despite studies demonstrating the effectiveness of using naloxone to treat itchiness in adults receiving morphine pain medications, there are not many studies in children. This study is designed to study how well naloxone works for treatment of itching in children


Detailed Summary:

Hypothesis: Naloxone co-administered simultaneously with standard Patient Controlled Analgesia (PCA) basal and bolus morphine will significantly reduce the incidence of Opioid Induced Pruritus (OIP) without affecting analgesia or opioid consumption in children.

Specific Objectives:

  1. To determine if naloxone (12 µg/ml) mixed in a single infusion with morphine (1 mg/ml) will be effective in the prevention of opioid induced pruritus (OIP).
  2. To determine if treatment with naloxone will result in attenuation of analgesia or an increase in opioid utilisation.
  3. To determine if treatment with naloxone will reduce other opioid induced side effects such as nausea and vomiting.

Methods: This study is divided into two phases. Phase 1 - Although, there are studies confirming the compatibility of morphine (4 mg/mL) with naloxone (16 µg/mL) in separate infusion pumps run into the same intravenous site, there are no studies confirming the chemical and physical compatibility of morphine and naloxone in the same syringe with the standard concentrations used at BCCH. Therefore, a compatibility and stability study of naloxone and morphine solution in the same syringe will be performed.

Phase 2 - Phase 2 is a blinded clinical trial where 70 subjects will be randomized to receive either morphine mixed with naloxone or morphine mixed with placebo.With institutional review board approval, and written parental/guardian informed consent (and assent if appropriate), we will recruit children, ages 5-16 years, receiving intravenous opioids via PCA for post-operative pain control. Subjects will be evaluated every 4 hr for pain scores, frequ
Sponsor: University of British Columbia

Current Primary Outcome: Pruritus incidence and intensity [ Time Frame: 2 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Self-report pain scores [ Time Frame: 2 days ]
  • Morphine, ondansetron, diphenhydramine utilization [ Time Frame: 2 days ]


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: February 17, 2010
Date Started: December 2010
Date Completion:
Last Updated: January 16, 2015
Last Verified: January 2015