Nausea
Conditions
Keywords
Narcotics, Nausea
Brief summary
We are doing this study to find out if extra medicine is needed to avoid the chance of nausea sometimes linked to narcotic pain medicine (for example, morphine, dilaudid, fentanyl). Some doctors always give medicine to prevent the possible side effect of nausea, while others do not. We are looking to see if this extra medicine is helpful in preventing nausea. The goal is to screen all patients with pain and enroll enough subjects to reach our goal of 164 evaluable study participants.
Detailed description
Patients will be randomized to one of two study groups. They will then be asked to rate their pain and nausea on a line graph. If the patient is a female of child bearing age, a urine pregnancy test will be done per standard of care. After this, an IV catheter will be placed in a vein in the patients arm. Pain medicine will be given through this IV per the doctor's order. With this medicine, patients will be given 10 milliliters (2 teaspoons) of either Sodium Chloride (salt water) or Phenergan mixed with Sodium Chloride (salt water). Phenergan is a medication typically used to help with nausea and is a common ingredient in prescription cough medicine. After this is finished, patients will be asked to rate their pain and nausea in 30 minutes, and again 1, 2, and 4 hours later. If the doctor decides the patient is able to be discharged from the emergency room before the 4 hours are up, they will be asked to rate your pain and nausea again before going home, and the study will be stopped at that time.
Interventions
DRUGSaline
10 c of saline
DRUGPhenergan
Physician ordered dose
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient in Christian Care Emergency Department 2. Require intravenous narcotics for painful condition 3. ≥18 years of age 4. Able to visually rate amount of pain and nausea
Exclusion criteria
1. Hypersensitivity to promethazine or opioids 2. Patient requesting anti-emetic at enrollment 3. Narcotic administration in last 6 hours 4. Pregnancy or currently breast-feeding 5. Known seizure disorder 6. Medical Instability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Who Became Nauseated After IV Opiate Administration. | 4 hours post opiate administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic | 13 |
| Promethazine Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline. | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Placebo | Promethazine | Total |
|---|---|---|---|
| Age, Customized Greater than or equal to 18 | 12 participants | 13 participants | 25 participants |
| Sex/Gender, Customized | NA participants | NA participants | NA participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
Number of Patients Who Became Nauseated After IV Opiate Administration.
Time frame: 4 hours post opiate administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients Who Became Nauseated After IV Opiate Administration. | 5 participants |
| Promethazine | Number of Patients Who Became Nauseated After IV Opiate Administration. | 4 participants |