Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
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|ClinicalTrials.gov Identifier: NCT02774148|
Recruitment Status : Terminated (Proved difficult to consent patient population due to comorbidities)
First Posted : May 17, 2016
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture||Drug: IV Acetaminophen Drug: PO Acetaminophen||Phase 4|
Surgeons involved in this research agree to the randomization of patients into one of two groups. After informed consent, patients will be randomly assigned in a 1:1 ratio to the treatment group or the control group.
Group 1: This group will serve as the control group, and will be scheduled to receive one gram (1g) acetaminophen PO every 8 hours.
Group 2: This group will serve as the treatment group, and will be scheduled to receive one gram (1g) acetaminophen IV every 8 hours
The standardized pain control protocol for hip fracture patients will be initiated for all patients. The pain protocol will be initiated at hospital admission, and after three postoperative doses of the group assigned acetaminophen all patients will be switched to one gram scheduled acetaminophen PO in preparation for hospital discharge.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: PO Acetaminophen
1,000mg Acetaminophen po every 8 hours until discharge.
Drug: PO Acetaminophen
The patient will receive 1,000mg po Acetaminophen every 8 hours.
Other Name: Tylenol
Experimental: IV Acetaminophen
1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.
Drug: IV Acetaminophen
The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
Other Name: Ofirmev
- Pain Score [ Time Frame: 6 days ]Pain scores will be compared between the two groups.
- The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient. [ Time Frame: 6 days ]The amount of opioid pain medication a patient receives will be recorded and the Morphine equivalents will be determined by an opioid dose calculator. The morphine equivalents will be compared between the two groups.
- Timing of First Day of Ambulation. [ Time Frame: 6 days ]The timing of the first day of ambulation will be compared between the two groups.
- Distance Ambulated [ Time Frame: 6 days ]The distance ambulated will be compared between the two groups.
- Hospital Stay [ Time Frame: 2 weeks ]Length of hospital stay will be compared between the two groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774148
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|Principal Investigator:||Andrew R. Fras, MD||Spectrum Health Hospitals|