Trial Outcomes & Findings for Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents (NCT NCT00330343)

Results Overview

incidence of nausea, vomiting, pruritus following naloxone infusion

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

0-48 hours after infusion begins

Results posted on

2017-07-19

75 participants were consented, but only 64 participants participated in this study and were placed in the experimental arm.

Reasons for withdrawal
Measure	Naloxone
Overall Study Lost to Follow-up	5

Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents

Baseline characteristics by cohort
Measure	Group 1 n=64 Participants
Age, Categorical <=18 years	64 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	12 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	64 Participants n=5 Participants

Timeframe: 0-48 hours after infusion begins

incidence of nausea, vomiting, pruritus following naloxone infusion

Outcome measures
Measure	Naloxone n=64 Participants
Number of Participants With Naloxone Side Effects	32 participants Interval 10.0 to 60.0

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Group 1 n=59 participants at risk
Gastrointestinal disorders Nausea, Vomiting or pruritis	54.2% 32/59 • Number of events 59

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