Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

Post Operative Pain Clinical Trial

Official title:

Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01149616
• Other study ID #: 2009P000345
• Status: Terminated
• Phase: Phase 4
• First received: June 22, 2010
• Last updated: June 29, 2017
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the opiate sparing effects of intravenously administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with well known antiemetic effects. However, the analgesic effects of dexamethasone have not been adequately researched. Following surgery, patients are typically discharged home with PO opiates to manage post-operative pain. The investigators believe that by using VAS (Visual Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1) when compared to placebo.

Description:

Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients undergoing ambulatory knee arthroscopy surgery

• Must provide phone contact number and agree to phone followup on post operative day 1

Exclusion Criteria:

• Patients with major systemic disease

• Allergy or intolerance to study drug

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Dexamethasone 8mg iv x1
Dexamethasone 8mg iv x1
• placebo
2 ml normal saline IV x1

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative VAS Pain Scale	Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.	24 hours
Secondary	Amount of Postop Narcotic Usage	Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge	24 hours
Secondary	Postop Nausea	NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.	24 hours