PainNCT01265056
The Effect of Neurontin on Pain Management in the Acutely Burned Patient
A study testing Gabapentin in people with Pain and Burn Injury, run by Lucy A Wibbenmeyer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Burn Injury
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All admitted patients with LOS expected to be > 48 hours (usually burn injury > 5%)
- > 18 years of age
- Thermal injury to skin
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Burn Center
Iowa City, Iowa, 52241
About this study
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.
Read the detailed description
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).
- Conditions
- Pain, Burn Injury
- Being tested
- Gabapentin, Placebo
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
On Study day 1: 1200mg (single dose).
Study day 2,3: 300mg TID, 900mg daily.
Study day 4-7: 600mg TID 1800mg* daily.
Study day 8-11: 800mg TID 2400mg* daily [Optional increase to 2400 if pain scores are still 4 on NRS]
Study day 11: 1200mg TID 3600mg* daily [Optional increase to 3600 if pain scores are still >4 on NRS]
- May revert back to prior dose if adverse symptoms occur and are thought to be drug related. Up titration then will be preformed in 48 hours following deexcalation.
PlaceboDrug
Sugar Pill is administered similar to the protocol used for the investigational drug.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo Receives: Drug: Placebo |
| Gabapentin | Experimental | Gabapentin Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)
Measured: From time of enrollment to 2 weeks after being discharged
Secondary outcomes (2)
Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups
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.
Measured: First Clinic Follow Up After Discharge
Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)
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.
Measured: First Clinic Follow Up After Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucy A Wibbenmeyer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucy A Wibbenmeyer, University of Iowa
- Investigators
- Lucy Wibbenmeyer, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265056
- Sponsor's protocol ID
- 200909736
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2010
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Researchers can contact me (lucy-wibbenmeyer@uiowa.edu) for study protocol or statistical plan.
Publications
Gibran NS; Committee on Organization and Delivery of Burn Care, American Burn Association. Practice Guidelines for burn care, 2006. J Burn Care Res. 2006 Jul-Aug;27(4):437-8. doi: 10.1097/01.BCR.0000226084.26680.56. No abstract available.
PubMed 16819344Cuignet O, Pirson J, Soudon O, Zizi M. Effects of gabapentin on morphine consumption and pain in severely burned patients. Burns. 2007 Feb;33(1):81-6. doi: 10.1016/j.burns.2006.04.020. Epub 2006 Oct 30.
PubMed 17071002Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD. Burn injury pain: the continuing challenge. J Pain. 2007 Jul;8(7):533-48. doi: 10.1016/j.jpain.2007.02.426. Epub 2007 Apr 16.
PubMed 17434800Dierking G, Duedahl TH, Rasmussen ML, Fomsgaard JS, Moiniche S, Romsing J, Dahl JB. Effects of gabapentin on postoperative morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):322-7. doi: 10.1111/j.0001-5172.2004.0329.x.
PubMed 14982565Gray P, Williams B, Cramond T. Successful use of gabapentin in acute pain management following burn injury: a case series. Pain Med. 2008 Apr;9(3):371-6. doi: 10.1111/j.1526-4637.2006.00149.x.
PubMed 18366516Dworkin RH. An overview of neuropathic pain: syndromes, symptoms, signs, and several mechanisms. Clin J Pain. 2002 Nov-Dec;18(6):343-9. doi: 10.1097/00002508-200211000-00001.
PubMed 12441827Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice ASC, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007 Dec 5;132(3):237-251. doi: 10.1016/j.pain.2007.08.033. Epub 2007 Oct 24.
PubMed 17920770
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurontin on Pain Management in the Acutely Burned Patient
- ClinicalTrials.gov ID
- NCT01265056
- Acronym / sponsor ID
- 200909736
- Conditions
- Pain, Burn Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Lucy A WibbenmeyerUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Posted 26 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo |
| Gabapentin | Experimental | Drug: GabapentinGabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All admitted patients with LOS expected to be > 48 hours (usually burn injury > 5%)
- > 18 years of age
- Thermal injury to skin
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: NeurontinOn Study day 1: 1200mg (single dose). Study day 2,3: 300mg TID, 900mg daily. Study day 4-7: 600mg TID 1800mg* daily. Study day 8-11: 800mg TID 2400mg* daily [Optional increase to 2400 if pain scores are still 4 on NRS] Study day 11: 1200mg TID 3600mg* daily [Optional increase to 3600 if pain scores are still >4 on NRS] * May revert back to prior dose if adverse symptoms occur and are thought to be drug related. Up titration then will be preformed in 48 hours following deexcalation. | Drug | Gabapentin |
| PlaceboSugar Pill is administered similar to the protocol used for the investigational drug. | Drug | Sugar Pill |
Primary outcome
Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)
Time frame: From time of enrollment to 2 weeks after being discharged
2 secondary outcomes
Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups
Time frame: First Clinic Follow Up After Discharge
Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)
Time frame: First Clinic Follow Up After Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16819344Gibran NS; Committee on Organization and Delivery of Burn Care, American Burn Association. Practice Guidelines for burn care, 2006. J Burn Care Res. 2006 Jul-Aug;27(4):437-8. doi: 10.1097/01.BCR.0000226084.26680.56. No abstract available.
- Background: PubMed 17071002Cuignet O, Pirson J, Soudon O, Zizi M. Effects of gabapentin on morphine consumption and pain in severely burned patients. Burns. 2007 Feb;33(1):81-6. doi: 10.1016/j.burns.2006.04.020. Epub 2006 Oct 30.
- Background: PubMed 17434800Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD. Burn injury pain: the continuing challenge. J Pain. 2007 Jul;8(7):533-48. doi: 10.1016/j.jpain.2007.02.426. Epub 2007 Apr 16.
- Background: PubMed 14982565Dierking G, Duedahl TH, Rasmussen ML, Fomsgaard JS, Moiniche S, Romsing J, Dahl JB. Effects of gabapentin on postoperative morphine consumption and pain after abdominal hysterectomy: a randomized, double-blind trial. Acta Anaesthesiol Scand. 2004 Mar;48(3):322-7. doi: 10.1111/j.0001-5172.2004.0329.x.
- Background: PubMed 18366516Gray P, Williams B, Cramond T. Successful use of gabapentin in acute pain management following burn injury: a case series. Pain Med. 2008 Apr;9(3):371-6. doi: 10.1111/j.1526-4637.2006.00149.x.
- Background: PubMed 12441827Dworkin RH. An overview of neuropathic pain: syndromes, symptoms, signs, and several mechanisms. Clin J Pain. 2002 Nov-Dec;18(6):343-9. doi: 10.1097/00002508-200211000-00001.
- Background: PubMed 17920770Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice ASC, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain. 2007 Dec 5;132(3):237-251. doi: 10.1016/j.pain.2007.08.033. Epub 2007 Oct 24.
- Individual participant dataSharing planned: Yes. Researchers can contact me (lucy-wibbenmeyer@uiowa.edu) for study protocol or statistical plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Wibbenmeyer, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Pain and Burn Injury, run by Lucy A Wibbenmeyer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents) (time frame: From time of enrollment to 2 weeks after being discharged). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265056, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.