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| Sponsored by: |
Christiana Care Health Services |
|---|---|
| Information provided by: | Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00541671 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Nausea |
Drug: Saline Drug: Phenergan |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Prevention of Narcotic-induced Nausea With Promethazine, a Randomized, Double-blind Placebo-controlled Trial |
| Estimated Enrollment: | 164 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
|
Drug: Saline
10 c of saline
|
|
2: Active Comparator
Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
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Drug: Phenergan
Physician ordered dose
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Delaware | |
| Christiana Care Health Services | |
| Newark, Delaware, United States, 19718 | |
| Principal Investigator: | Michael Perraut, MD | Christiana Care Health Services |
More Information
| Responsible Party: | Christiana Care Health Services ( Melissa Bollinger ) |
| Study ID Numbers: | 27002 |
| Study First Received: | October 5, 2007 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00541671 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Narcotics Nausea |
|
Neurotransmitter Agents Signs and Symptoms, Digestive Central Nervous System Depressants Narcotics Anti-Allergic Agents Histamine Signs and Symptoms Promethazine |
Histamine Antagonists Antipruritics Histamine H1 Antagonists Histamine phosphate Nausea Peripheral Nervous System Agents Analgesics Diphenhydramine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Physiological Effects of Drugs Central Nervous System Depressants Histamine Agents Narcotics Anti-Allergic Agents Pharmacologic Actions Signs and Symptoms Promethazine |
Histamine Antagonists Sensory System Agents Therapeutic Uses Antipruritics Histamine H1 Antagonists Nausea Peripheral Nervous System Agents Analgesics Central Nervous System Agents Dermatologic Agents |
