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Pruritus | Naloxone for the Treatment of Opioid-Induced Pruritus

Pruritus research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pruritus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:NaloxoneBasal 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.

Drug:Saline/MorphineBasal 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Naloxone/morphineNaloxone (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.

saline/morphinePatients 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

Study Status

Completed

Start Date: December 2010

Completed Date: April 2013

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Pruritus incidence and intensity

Secondary Outcome: Self-report pain scores

Study sponsors, principal investigator, and references

Principal Investigator: Gillian Lauder, Dr.

Lead Sponsor: University of British Columbia

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01071057

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