Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?

Hip Fracture Clinical Trial

Official title:

Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02774148
• Other study ID #: 2016-225
• Status: Terminated
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2023
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).

2. Age = 65 years.

3. Low energy mechanism.

4. Hip fracture fixation performed within 48 hours of injury.

5. English speaking.

6. Anticipated medical optimization for operative fixation.

7. No other major trauma.

Exclusion Criteria:

1. Unable to provide informed consent (dementia, limited decision making capacity)

2. Admitted by medical service for significant co-morbidities

3. Retained hardware around the affected hip

4. Infection around the affected hip

5. Transfer patients with a length of stay > 24 hours at the transferring hospital

6. Known allergy to acetaminophen

7. Current use of narcotics

8. Receiving a regional anesthetic block at any point during the hospitalization

9. Known history of hepatic disease (hepatitis, cirrhosis)

10. Weight < 50kg

11. Prisoner

12. Involved in another clinical trial that would interfere with the intervention of this study

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• IV Acetaminophen
The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
• PO Acetaminophen
The patient will receive 1,000mg po Acetaminophen every 8 hours.

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Pain scores will be compared between the two groups.	6 days
Secondary	The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.	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.	6 days
Secondary	Timing of First Day of Ambulation.	The timing of the first day of ambulation will be compared between the two groups.	6 days
Secondary	Distance Ambulated	The distance ambulated will be compared between the two groups.	6 days
Secondary	Hospital Stay	Length of hospital stay will be compared between the two groups.	2 weeks