Post-operative Pain Clinical Trial
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
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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