Naloxone for the Treatment of Opioid-Induced Pruritus
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2/Phase 3

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 description: 
      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, frequency
      of vomiting, nausea, pruritus, sedation, and respiratory depression. At 24 and 48 hr, the
      total morphine consumption will be calculated.

      Data analysis: Differences in the incidence and intensity of pruritus between the two groups
      will be compared. We will review side effects using the following control variables: (1)
      demographic data; and (2) summation of opioid use in each 4 hr period for total opioid
      consumption. ANOVA and crosstabs will be used where appropriate to analyze data.
    

Intervention name(s): Naloxone; Saline/Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Basal infusion of 20µg/kg/hour, bolus dose of 20µg /kg, lockout of 5 minutes with hourly maximum not to exceed 150µg /kg/hr, maximum 6 bolus doses. Subject pain relief will be assessed and documented by nursing staff and supervised by the Acute Pain Service (APS). Morphine will be titrated to subject need according to APS PCA protocol.; Basal infusion of 20µg/kg/hour, bolus dose of 20µg /kg, lockout of 5 minutes with hourly maximum not to exceed 150µg /kg/hr, maximum 6 bolus doses. Subject pain relief will be assessed and documented by nursing staff and supervised by the Acute Pain Service (APS). Morphine will be titrated to subject need according to APS PCA protocol.
Intervention MeSH terms: Morphine; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: opioid-induced pruritus; naloxone