Anxiety, Pain
Conditions
Keywords
Pain not controled by morphine, Anxiety not controled by lorazepam
Brief summary
Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.
Interventions
DRUGclonidine
3-5 microgram per kilogram every 6 hours for 10 days
DRUGplacebo
1 dose every 6 hours
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Pain not controled by morphine * Anxiety not controled by lorazepam * Burn injuries of 20% or greater * Burn type: scald or flame
Exclusion criteria
* Small burn injury * Electrical burns
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | Average of the 10 days | The scale name is FACES (Faces Pain Rating Scale). Subjects were asked rate your WORST PAIN today (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Reduction | Average of the 10 days | The Fear Thermometer measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days. |
Countries
United States
Participant flow
Recruitment details
Patients recruited in the medical clinic. Recruitment occured between 11/10/04-7/16/05.
Pre-assignment details
All participants were eligible to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group clonidine : 3-5 microgram per kilogram every 6 hours for 10 days | 9 |
| Control Group placebo : 1 dose every 6 hours | 0 |
| Total | 9 |
Baseline characteristics
| Characteristic | Total | Experimental Group |
|---|---|---|
| Age, Categorical <=18 years | 9 participants | 9 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Age, Continuous | 7.8 years STANDARD_DEVIATION 3.2 | 7.8 years STANDARD_DEVIATION 3.2 |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 8 participants | 8 participants |
| Region of Enrollment United States | 9 participants | 9 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 0 |
| serious Total, serious adverse events | 0 / 9 | 0 / 0 |
Outcome results
Primary
Pain Reduction
The scale name is FACES (Faces Pain Rating Scale). Subjects were asked rate your WORST PAIN today (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged.
Time frame: Average of the 10 days
Population: Determined by the number of patients recruited.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Pain Reduction | .73 units on a scale |
Secondary
Anxiety Reduction
The Fear Thermometer measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days.
Time frame: Average of the 10 days
Population: Patients analyzed were all patients consented.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Anxiety Reduction | .76 units on a scale |