Nausea, Post Operative Pain
Conditions
Brief 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.
Detailed description
Findings of Modest improvement in pain scores and postoperative nausea at 24 hours with Dexamethasone
Interventions
DRUGDexamethasone 8mg iv x1
Dexamethasone 8mg iv x1
DRUGplacebo
2 ml normal saline IV x1
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative VAS Pain Scale | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Postop Narcotic Usage | 24 hours | 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 |
| Postop Nausea | 24 hours | NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined. |
Countries
United States
Participant flow
Recruitment details
2010
Participants by arm
| Arm | Count |
|---|---|
| Intervention Dexamethasone 8mg iv x 1
Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1 | 41 |
| Placebo placebo
placebo: placebo administered IV x1 | 41 |
| Total | 82 |
Baseline characteristics
| Characteristic | Placebo | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 82 Participants | 41 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 41 participants | 82 participants | 41 participants |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Post Operative VAS Pain Scale | 1.88 units on a scale | Standard Deviation 0.3 |
| Placebo | Post Operative VAS Pain Scale | 3.73 units on a scale | Standard Deviation 0.5 |
p-value: 0.007ANOVA
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
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Amount of Postop Narcotic Usage | 1 number of tablets |
| Placebo | Amount of Postop Narcotic Usage | 2 number of tablets |
p-value: 0.006ANOVA
Secondary
Postop Nausea
NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Postop Nausea | 0 units on a scale |
| Placebo | Postop Nausea | 0 units on a scale |
p-value: 0.05ANOVA