Trial Outcomes & Findings for Burn Healing and Analgesia With Propranolol (NCT NCT00934947)

Results Overview

Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Study days 5, 7, 10, 13, 17 and 19

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Sugar Pill Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell.
Overall Study STARTED	23	22
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugar Pill Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell.
Overall Study Adverse Event	0	2

Baseline Characteristics

Burn Healing and Analgesia With Propranolol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=23 Participants Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=22 Participants Identical to sugar pill in sight, taste, and smell.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 11 • n=5 Participants	31 years STANDARD_DEVIATION 9 • n=7 Participants	32 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Study days 5, 7, 10, 13, 17 and 19

Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.

Outcome measures

Outcome measures
Measure	Sugar Pill n=23 Participants Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=20 Participants Identical to sugar pill in sight, taste, and smell.
Overall Pain Trajectory Slopes	-0.22 Numeric Rating Scale Score Change/Day Interval -0.25 to -0.19	-0.16 Numeric Rating Scale Score Change/Day Interval -0.19 to -0.13

SECONDARY outcome

Timeframe: 6 weeks after injury timepoint was chosen for this analysis

Population: The number of participants who reported sleep quality at the 6 week time point are included in the analysis.

Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep.

Outcome measures

Outcome measures
Measure	Sugar Pill n=16 Participants Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=22 Participants Identical to sugar pill in sight, taste, and smell.
Sleep Quality	6.75 units on a scale Standard Deviation 2.49	7.46 units on a scale Standard Deviation 2.02

SECONDARY outcome

Timeframe: Week 6 after injury was chosen as the main timepoint of interest

Population: The number of participants who reported itch at the 6 week time point are included in the analysis.

Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms.

Outcome measures

Outcome measures
Measure	Sugar Pill n=16 Participants Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=22 Participants Identical to sugar pill in sight, taste, and smell.
Itch Symptoms	1.91 units on a scale Standard Deviation 1.81	2.61 units on a scale Standard Deviation 2.89

SECONDARY outcome

Timeframe: 6 weeks after injury was chosen as the main timepoint of interest

Population: The number of patients represents the number of participants responding at 6 weeks after injury.

Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.

Outcome measures

Outcome measures
Measure	Sugar Pill n=15 Participants Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=22 Participants Identical to sugar pill in sight, taste, and smell.
Anxiety Symptoms	15.27 units on scale Standard Deviation 4.62	14.23 units on scale Standard Deviation 3.87

Adverse Events

Sugar Pill

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Propranolol, Propanolol ER

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sugar Pill n=23 participants at risk Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=22 participants at risk Identical to sugar pill in sight, taste, and smell.
Blood and lymphatic system disorders Thrombisis	4.3% 1/23 • Number of events 1	0.00% 0/22

Other adverse events

Other adverse events
Measure	Sugar Pill n=23 participants at risk Identical to active drug in sight, taste, and smell.	Propranolol, Propanolol ER n=22 participants at risk Identical to sugar pill in sight, taste, and smell.
Gastrointestinal disorders Nausea	26.1% 6/23 • Number of events 6	36.4% 8/22 • Number of events 8

Additional Information

Samuel McLean

UNC Department of Anesthesiology

Phone: 919-966-7315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place