BURN HELP: Burn Healing and Analgesia With Propranolol

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT00934947
• Collaborator: (none)
• Enrollment: 45
• Locations: 4
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 11.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.

Condition or Disease	Intervention/Treatment	Phase
Burns; Pain	Drug: Propranolol; Drug: Placebo; Drug: Propanolol	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugar pill	Drug: Placebo; sugar pill; Other Names: Sugar pill
Experimental: Propranolol, Propanolol ER	Drug: Propranolol; 40 mg; Other Names: Inderal Innopran ; Drug: Propanolol; 120 mg twice per day; Other Names: Inderal Innopran

Outcome Measures

Primary Outcome Measures

1. Overall Pain Trajectory Slopes [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.

Secondary Outcome Measures

1. Sleep Quality [6 weeks after injury timepoint was chosen for this 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.

2. Itch Symptoms [Week 6 after injury was chosen as the main timepoint of interest]

   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.

3. Anxiety Symptoms [6 weeks after injury was chosen as the main timepoint of interest]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Thermal burn

• Greater than or equal to 18 years of age

• Less than 60 years of age

• Able to speak and read English

Exclusion Criteria:

• Intubated

• Clinically unstable

• Other substantial comorbid injury (e.g. long bone fracture)

• Heart block greater than first degree (EKG)

• History of coronary artery disease

• History of congestive heart failure

• Asthma (within past 10 years, induced by a beta-blocker, or receiving current treatment)

• Pregnant

• Prisoner

• Psychotic, suicidal, or homicidal

• Diabetic

• Hepatic failure (acute or chronic)

• Renal failure (acute or chronic)

• History of hyperthyroidism unless taking synthroid or other thyroid hormone replacement

• Exceeds daily acceptable chronic opioid use prior to burn

• Interacting medication

• Received propranolol within the last 6 months

• Multiple severe allergic reactions

• On daily methylphenidate or similar stimulant medication

• Unwilling to use medically acceptable birth control (if childbearing potential)

• Breastfeeding

• Severe peripheral vascular disease or vasospastic disorder

• Bradycardia that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history

• Other criteria that in investigator's opinion makes participant poor candidate for the trial

• Cancer (except basal cell cancer)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington, D.C.	District of Columbia	United States	20011
2	North Carolina Jaycee Burn Center	Chapel Hill	North Carolina	United States	27514
3	Wake Forest University Baptist	Wake Forest	North Carolina	United States	27587
4	Crozer Chester Medical Center	Upland	Pennsylvania	United States	19102

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Samuel McLean, MD, MPh, University of North Carolina, Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NC Jaycee Burn Center

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00934947
• Other Study ID Numbers: 09-0681
• First Posted: Jul 8, 2009
• Last Update Posted: Nov 17, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by University of North Carolina, Chapel Hill: Burns; Pain
• Additional relevant MeSH terms: Burns; Propranolol

Study Results

Participant Flow

Arm/Group Title	Sugar Pill	Propranolol, Propanolol ER
Arm/Group Description	Identical to active drug in sight, taste, and smell.	Identical to sugar pill in sight, taste, and smell.
Period Title: Overall Study
STARTED	23	22
COMPLETED	23	20
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Sugar Pill	Propranolol, Propanolol ER	Total
Arm/Group Description	Identical to active drug in sight, taste, and smell.	Identical to sugar pill in sight, taste, and smell.	Total of all reporting groups
Overall Participants	23	22	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 100%	22 100%	45 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (11)	31 (9)	32 (10)
Sex: Female, Male (Count of Participants)
Female	4 17.4%	7 31.8%	11 24.4%
Male	19 82.6%	15 68.2%	34 75.6%
Region of Enrollment (participants) [Number]
United States	23 100%	22 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Overall Pain Trajectory Slopes
Description	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.
Time Frame	Study days 5, 7, 10, 13, 17 and 19

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Propranolol, Propanolol ER
Arm/Group Description	Identical to active drug in sight, taste, and smell.	Identical to sugar pill in sight, taste, and smell.
Measure Participants	23	20
Least Squares Mean (95% Confidence Interval) [Numeric Rating Scale Score Change/Day]	-0.22	-0.16

2. Secondary Outcome

Title	Sleep Quality
Description	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.
Time Frame	6 weeks after injury timepoint was chosen for this analysis

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Propranolol	Placebo
Arm/Group Description	Individuals who were randomized to receive propranolol following an intention to treat analysis	Individuals enrolled in the study who received placebo
Measure Participants	16	22
Mean (Standard Deviation) [units on a scale]	6.75 (2.49)	7.46 (2.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, Propranolol, Propanolol ER
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.36
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Itch Symptoms
Description	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.
Time Frame	Week 6 after injury was chosen as the main timepoint of interest

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Propranolol	Placebo
Arm/Group Description	Individuals who were randomized to receive propranolol following an intention to treat analysis	Individuals enrolled in the study who received placebo
Measure Participants	16	22
Mean (Standard Deviation) [units on a scale]	1.91 (1.81)	2.61 (2.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, Propranolol, Propanolol ER
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.32
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Anxiety Symptoms
Description	Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
Time Frame	6 weeks after injury was chosen as the main timepoint of interest

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Propranolol	Placebo
Arm/Group Description	Individuals who were randomized to receive propranolol following an intention to treat analysis	Individuals enrolled in the study who received placebo
Measure Participants	15	22
Mean (Standard Deviation) [units on scale]	15.27 (4.62)	14.23 (3.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, Propranolol, Propanolol ER
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.48
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Sugar Pill		Propranolol, Propanolol ER
Arm/Group Description	Identical to active drug in sight, taste, and smell.		Identical to sugar pill in sight, taste, and smell.
All Cause Mortality
	Sugar Pill		Propranolol, Propanolol ER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sugar Pill		Propranolol, Propanolol ER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.3%)		0/22 (0%)
Blood and lymphatic system disorders
Thrombisis	1/23 (4.3%)	1	0/22 (0%)	0
Other (Not Including Serious) Adverse Events
	Sugar Pill		Propranolol, Propanolol ER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/23 (26.1%)		8/22 (36.4%)
Gastrointestinal disorders
Nausea	6/23 (26.1%)	6	8/22 (36.4%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.