Trial Outcomes & Findings for The Effect of Neurontin on Pain Management in the Acutely Burned Patient (NCT NCT01265056)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

From time of enrollment to 2 weeks after being discharged

Results posted on

2018-01-23

Participant Flow

Recruitment period 1/2010 to 9/13/2011. Patients were recruited for the study if they met criteria and were admitted for burn injuries.

There were no significant events or approaches following enrollment. Patients were randomized into groups.

Participant milestones

Participant milestones
Measure	Sugar Pill Patients in this group received a sugar pill which looked identical to gabapentin.	Gabapentin Patients in this group received gabapentin which looked just like the sugar pill.
Initial Study Period STARTED	26	27
Initial Study Period COMPLETED	24	25
Initial Study Period NOT COMPLETED	2	2
Follow up STARTED	26	27
Follow up COMPLETED	19	24
Follow up NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugar Pill Patients in this group received a sugar pill which looked identical to gabapentin.	Gabapentin Patients in this group received gabapentin which looked just like the sugar pill.
Initial Study Period Withdrawal by Subject	1	1
Follow up Lost to Follow-up	7	3

Baseline Characteristics

The Effect of Neurontin on Pain Management in the Acutely Burned Patient

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=26 Participants Patients in this group received a sugar pill which looked identical to gabapentin.	Gabapentin n=27 Participants Patients in this group received gabapentin which looked just like the sugar pill.	Total n=53 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	40.6 years STANDARD_DEVIATION 14.3 • n=5 Participants	42.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	41.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	27 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: From time of enrollment to 2 weeks after being discharged

Population: This was an intention to treate analysis. We measured the oral morphine equivalents both groups were administered.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Patients received a sugar pill similar to gabapentin.	Gabapentin n=27 Participants Patients received gabapentin.
Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)	7.0 morphine equivalents Standard Deviation 8.4	6.7 morphine equivalents Standard Deviation 11.6

SECONDARY outcome

Timeframe: First Clinic Follow Up After Discharge

The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Patients received a sugar pill similar to gabapentin.	Gabapentin n=24 Participants Patients received gabapentin.
Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups	9 units on a scale Standard Deviation 7.5	7.3 units on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: First Clinic Follow Up After Discharge

The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Patients received a sugar pill similar to gabapentin.	Gabapentin n=24 Participants Patients received gabapentin.
Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)	34.9 units on a scale Standard Deviation 15.7	36.0 units on a scale Standard Deviation 19.5

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gabapentin

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

Jennifer Lassner

The University of Iowa

Phone: 319-335-2123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place