An interventional study of Gabapentin and Diphenhydramine in Pain, sponsored by Michelle Kinney. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Michelle Kinney · Not applicable, Interventional, and Treatment
One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.
The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.
This is the only study on the registry with Michelle Kinney as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Preoperative gabapentin 600 mg orally within 2 hours prior to surgery.
Drug: Gabapentin
Diphenhydramine 12.5 mg orally 2 hours preoperatively.
Drug: Diphenhydramine
gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
Also known as: Neurontin
Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
Also known as: Benadryl
Average Pain Score at Rest
Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.
Time frame: 48 hours
Average Pain Score With Coughing the First Morning Following Surgery
Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.
Time frame: First morning following surgery
Average Pain Score With Coughing on Second Morning After Surgery
Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
Time frame: Second morning after surgery
Opioid Consumption in First 24 Hours Postoperatively
Time frame: 24 hours
Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively
Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.
Time frame: 3 months postoperatively
Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively
Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively
Time frame: 48 hours postoperatively
| Milestone | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Started | 72 | 74 |
| Completed | 57 | 63 |
| Not completed | 15 | 11 |
Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.
| Units on a scale | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Average Pain Score at Rest | 3.1 ± 1.9 | 2.9 ± 1.8 |
| mg | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Opioid Consumption in First 24 Hours Postoperatively | 111.9 ± 116.9 | 118.1 ± 94.7 |
Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.
| Participants | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | 37 | 38 |
Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.
| Units on a scale | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Average Pain Score With Coughing the First Morning Following Surgery | 5.2 ± 2.9 | 5.0 ± 2.6 |
Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
| Unites on a scale | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Average Pain Score With Coughing on Second Morning After Surgery | 5.0 ± 2.2 | 5.1 ± 2.5 |
Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively
| mg | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | 114.4 ± 106.8 | 121.6 ± 110.3 |
Collected over 48 hours following entrance into the recovery room.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin Preoperatively | — | 0/57 (0%) | 4/57 (7%) |
| Active Placebo | — | 0/63 (0%) | 4/63 (6.3%) |
| Event | Gabapentin Preoperatively | Active Placebo |
|---|---|---|
| SedationNervous system disorders | 4/57 | 4/63 |
| Age, Categorical(Participants) | Gabapentin Preoperatively | Active Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 33 | 38 | 71 |
| >=65 years | 39 | 36 | 75 |
| Age, Continuous(years) | Gabapentin Preoperatively | Active Placebo | Total |
|---|---|---|---|
| Mean | 64 ± 7 | 64 ± 7 | 64 ± 7 |
| Sex: Female, Male(Participants) | Gabapentin Preoperatively | Active Placebo | Total |
|---|---|---|---|
| Female | 32 | 38 | 70 |
| Male | 40 | 36 | 76 |
| Region of Enrollment(participants) | Gabapentin Preoperatively | Active Placebo | Total |
|---|---|---|---|
| United States | 72 | 74 | 146 |
Plan to share: No
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