Trial Outcomes & Findings for Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery (NCT NCT01531439)

Results Overview

Defined as time when awakening after surgery until tolerating orals.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

Assessed daily in hospital while in hospital until taking orals, average 4 days.

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Naloxone Infusion 0.5 mcg/kg/hr Naloxone: Naloxone infusion 0.5 mcg/kg/hr	Naloxone 2.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
Overall Study STARTED	41	43
Overall Study COMPLETED	37	42
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naloxone Infusion 0.5 mcg/kg/hr n=37 Participants Naloxone: Naloxone infusion 0.5 mcg/kg/hr	Naloxone 2.5 mcg/kg/hr n=42 Participants Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	42 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	37 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	41 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed daily in hospital while in hospital until taking orals, average 4 days.

Defined as time when awakening after surgery until tolerating orals.

Outcome measures

Outcome measures
Measure	Naloxone Infusion 0.5 mcg/kg/hr n=37 Participants Naloxone: Naloxone infusion 0.5 mcg/kg/hr	Naloxone 2.5 mcg/kg/hr n=42 Participants Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
Number of Hours Until Tolerating Oral Intake	25.9 hours Interval 19.4 to 29.8	25.0 hours Interval 18.8 to 28.0

SECONDARY outcome

Timeframe: Assessed daily while in hospital requiring PCA

Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported.

Outcome measures

Outcome measures
Measure	Naloxone Infusion 0.5 mcg/kg/hr n=37 Participants Naloxone: Naloxone infusion 0.5 mcg/kg/hr	Naloxone 2.5 mcg/kg/hr n=42 Participants Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
Severity of Itching	2.1 score on a scale, averaged Interval 0.6 to 3.7	1.9 score on a scale, averaged Interval 0.6 to 3.7

SECONDARY outcome

Timeframe: Assessed daily while in hospital requiring PCA.

Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported.

Outcome measures

Outcome measures
Measure	Naloxone Infusion 0.5 mcg/kg/hr n=37 Participants Naloxone: Naloxone infusion 0.5 mcg/kg/hr	Naloxone 2.5 mcg/kg/hr n=42 Participants Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
Severity of Nausea	2.0 score on a scale, averaged Interval 0.5 to 3.2	1.2 score on a scale, averaged Interval 0.3 to 2.8

SECONDARY outcome

Timeframe: Assessed by bedside nurse 3 times daily while requiring PCA

Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported.

Outcome measures

Outcome measures
Measure	Naloxone Infusion 0.5 mcg/kg/hr n=37 Participants Naloxone: Naloxone infusion 0.5 mcg/kg/hr	Naloxone 2.5 mcg/kg/hr n=42 Participants Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr
Severity of Pain	3.7 units on a scale, averaged Interval 2.7 to 5.1	4.1 units on a scale, averaged Interval 3.0 to 5.6

Adverse Events

Naloxone Infusion 0.5 mcg/kg/hr

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Naloxone 2.5 mcg/kg/hr

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ben Pieters

Children's Mercy Hospital

Phone: 816-234-3464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place