Naloxone for the Treatment of Opioid-Induced Pruritus

NCT01071057 | Completed Phase 2

• 1 other identifier: H09-03001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Pruritus

Keywords

opioid-induced pruritus; naloxone

Outcome Measures

Primary Outcomes (1)

• Pruritus incidence and intensity

  2 days

Secondary Outcomes (2)

• Self-report pain scores

  2 days

• Morphine, ondansetron, diphenhydramine utilization

  2 days

Study Arms (2)

Naloxone/morphine

ACTIVE COMPARATOR

Naloxone (12 µg/ml) mixed in a single infusion with morphine (1 mg/ml). The study solutions will be prepared by a pharmacist and diluted in saline to produce equal volumes to ensure proper blinding.

Drug: Naloxone

saline/morphine

PLACEBO COMPARATOR

Patients will be randomly assigned to one of two groups (Naloxone/morphine or saline/morphine) using computer-generated random numbers. On arrival to the PACU patients will be started on IV PCA and randomized study drug

Drug: Saline/Morphine

Interventions

Naloxone DRUG

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.

Naloxone/morphine

Saline/Morphine DRUG

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.

saline/morphine

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 5-18 years of age undergoing surgery at BCCH
• ASA I - II.
• Children receiving PCA morphine.
• Informed consent/assent provided by child/parent/guardian.

You may not qualify if:

• Children with known abnormal developmental profile.
• Children with known opioid allergy.
• Inability/failure to obtain informed consent/assent from parent/guardian/child.
• Children receiving concurrent opioids.
• Children with pre-existing pruritus from non-opioid related cause.
• Children receiving PCA hydromorphone or fentanyl.
• ASA 3 and above.
• Children who require admission to the Pediatric Intensive Care Unit (PICU). - Children involved in any investigational drug trial within the previous one month.
• Any child in the study that experiences unmanageable pruritus within the protocol time frame and is converted to hydromorphone will continue to be monitored for 48 hours. However, this will be taken into account during statistical analysis of study results. Appropriate conventional rescue medication for pruritus (diphenhydramine 0.5mg/kg IV 4hrly PRN) will be provided for any child who continues to experience pruritus.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

• West N, Ansermino JM, Carr RR, Leung K, Zhou G, Lauder GR. A naloxone admixture to prevent opioid-induced pruritus in children: a randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):891-900. doi: 10.1007/s12630-015-0380-5. Epub 2015 Apr 23.

  PMID: 25902891 DERIVED

MeSH Terms

Conditions

Pruritus

Interventions

Naloxone; Sodium Chloride; Morphine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Morphine Derivatives

Study Officials

• Gillian Lauder, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Roxane Carr, Dr.

  University of British Columbia

  STUDY DIRECTOR

• Mark Ansermino, Dr.

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)