Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients
|Post-operative Pain Respiratory Depression||Drug: Dexmedetomidine Other: Placebo (Normal Saline)||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Post-Operative Infusion of Low-Dose Dexmedetomidine for the Control of Post-Operative Pain in Thoracotomy Patients: A Randomized, Double-Blind, Controlled Pilot Study|
- Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm. [ Time Frame: An average of 24 hours, up to 30 hours per patient ]To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.
- Measure the Amount of Respiratory Depression in Each Groups [ Time Frame: Hours 6 to 16 ]Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.
|Study Start Date:||May 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Normal Saline
One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug.
|Other: Placebo (Normal Saline)|
Active Comparator: Dexmedetomidine
The second group (the study group) will receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 24 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU
Dexmedetomidine titrated over 24 hours
Other Name: Precedex, Dexdor Titrated 0.1 to 0.5 ug.kg.h-1
Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occurs with opioid administration. In addition, patients may be more alert with less opioid medication. Currently, dexmedetomidine is not approved for use longer than twenty-four hours and must only be administered in the Intensive Care Unit where patients can be continuously monitored.
This is a prospective, double-blinded, control group pilot study. One group (the control group) will receive a normal saline infusion and the second group (the treatment group) will receive low-dose Dexmedetomidine for up to 24 hours after they are admitted to an open nursing unit (not an Intensive Care Unit).
During the surgery, the anesthesiologist will administer dexmedetomidine during the surgical procedure after an optional loading dose. All patients will receive pain medication using a Patient Controlled Analgesia (PCA) pump as per standard practice. In addition, if the physician deems necessary, an On-Q Pain Pump will deliver local anesthetic surrounding the incision under direction of the surgeon.
Before discharge from the PACU or ICU, each subject will receive either low-dose dexmedetomidine or normal saline using a continuous infusion pump for up to 24 hours after the subject is discharged from either the PACU or the ICU to an open nursing unit. While on the open nursing unit patient vital signs, oxygen saturation, Ramsay score and pain score will recorded every two hours until the treatment drug is stopped.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345384
|United States, Texas|
|Baylor University Medical Center - Department of Anesthesiology|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Michael Ramsay, MD, MD||Baylor Health Care System|