Naloxone for the Treatment of Opioid-Induced Pruritus

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Treatments: Analgesics, Opioid; Morphine; Naloxone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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.