The Effect of Neurontin on Pain Management in the Acutely Burned Patient
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2018 |
| Start Date: | February 2010 |
| End Date: | September 2011 |
Burn patients have extreme pain. Opioids are the main agents used for analgesia. We therefore
propose a single center study to fruther assess the efficacy of neuropathic agents in
controlling the pain associated with acute thermal injury.
propose a single center study to fruther assess the efficacy of neuropathic agents in
controlling the pain associated with acute thermal injury.
The study was conducted in a 16-bed American Burn Association certified burn unit. Patients
age >18 years old, with at least a 5% burn injury and an expected length of stay (LOS) of 48
hours, were approached for enrollment in this prospective, placebo controlled randomized
study. Patients who were pregnant, lactating, prisoners or who had renal insufficiency were
excluded. After consent, patients were assigned to either placebo or Gp by random numbers
generated in Microsoft Excel (2010). Both the drug and the placebo were over-encapsulated to
appear identical. The placebo pills contained starch. The research clinical pharmacist was
the only unblinded staff member and did not participate in clinical care of the patients.
Following randomization, patients received a loading dose of study drug on day one and began
three times a day (TID) dosing per the dose escalation schedule the following day. At
discharge, patients were given a three day taper per the dose de-escalation schedule Patients
were assessed for completion of psychosocial adjustment (Brief Symptom Inventory, BSI, and
Sickness Inventory Profile, SIP) at their first clinic visit.
Agents used for pain control included: acetaminophen, non-steroidal anti-inflammatories,
morphine instantaneous release and morphine extended release. In the case of allergies or
ineffectiveness, other agents were occasionally used. Short acting morphine was ordered every
two hours prn and hydromorphone was ordered every four hours as needed. All were converted to
morphine equivalents.
The study was powered to detect a 22% difference in opioid consumption between the two groups
based on the work by Cuignet et al. It was estimated that a total of 50 patients were needed
to achieve an alpha of 0.05 and a beta of 0.80 to detect the difference in the primary
endpoint.
For statistical purposes, conversion tables were used to convert all opioid medications into
morphine equivalents with 1 morphine equivalents (ME)=30mg oral morphine. The primary outcome
variable (morphine consumption) were adjusted for days past injury. The BSI and SIP scales
were scored according to study directions.
Both an intention to treat and actual treatment analysis were performed using Stata 11.2 for
Windows (Stata Corp. College Station, Texas, U.S.A.). Continuous variables between groups
were analyzed with the students T test. Categorical variables were analyzed with the Chi
Square test or Fischer Exact Test where appropriate. A random effects model adjusting for
confounders was used to assess the effect of treatment on the outcome measures. The study was
approved by the University's Institutional Review Board and was registered with the clinical
trials association (200909736).
age >18 years old, with at least a 5% burn injury and an expected length of stay (LOS) of 48
hours, were approached for enrollment in this prospective, placebo controlled randomized
study. Patients who were pregnant, lactating, prisoners or who had renal insufficiency were
excluded. After consent, patients were assigned to either placebo or Gp by random numbers
generated in Microsoft Excel (2010). Both the drug and the placebo were over-encapsulated to
appear identical. The placebo pills contained starch. The research clinical pharmacist was
the only unblinded staff member and did not participate in clinical care of the patients.
Following randomization, patients received a loading dose of study drug on day one and began
three times a day (TID) dosing per the dose escalation schedule the following day. At
discharge, patients were given a three day taper per the dose de-escalation schedule Patients
were assessed for completion of psychosocial adjustment (Brief Symptom Inventory, BSI, and
Sickness Inventory Profile, SIP) at their first clinic visit.
Agents used for pain control included: acetaminophen, non-steroidal anti-inflammatories,
morphine instantaneous release and morphine extended release. In the case of allergies or
ineffectiveness, other agents were occasionally used. Short acting morphine was ordered every
two hours prn and hydromorphone was ordered every four hours as needed. All were converted to
morphine equivalents.
The study was powered to detect a 22% difference in opioid consumption between the two groups
based on the work by Cuignet et al. It was estimated that a total of 50 patients were needed
to achieve an alpha of 0.05 and a beta of 0.80 to detect the difference in the primary
endpoint.
For statistical purposes, conversion tables were used to convert all opioid medications into
morphine equivalents with 1 morphine equivalents (ME)=30mg oral morphine. The primary outcome
variable (morphine consumption) were adjusted for days past injury. The BSI and SIP scales
were scored according to study directions.
Both an intention to treat and actual treatment analysis were performed using Stata 11.2 for
Windows (Stata Corp. College Station, Texas, U.S.A.). Continuous variables between groups
were analyzed with the students T test. Categorical variables were analyzed with the Chi
Square test or Fischer Exact Test where appropriate. A random effects model adjusting for
confounders was used to assess the effect of treatment on the outcome measures. The study was
approved by the University's Institutional Review Board and was registered with the clinical
trials association (200909736).
Inclusion Criteria:
- All admitted patients with LOS expected to be > 48 hours (usually burn injury > 5%)
- > 18 years of age
- Thermal injury to skin
Exclusion Criteria:
- Prisoners
- Pregnant or nursing women
- Children <18 years of age
- Frostbite or non thermal injury to skin
- Renal insuffiency (creatinine clearance < 60mL/min) or failure (on renal replacement)
- Expected length of stay < 48 hours (this usually includes burn <5%
We found this trial at
1
site
Click here to add this to my saved trials
