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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
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hip Fracture
Interventions Drug: IV Acetaminophen
Drug: PO Acetaminophen
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title PO Acetaminophen IV Acetaminophen Total
Hide Arm/Group Description

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Only one patient was enrolled, therefore data was not sufficient to run an analysis.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race and Ethnicity Not Collected   [1] 
Number Analyzed 0 participants 0 participants 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Pain Score
Hide Description Pain scores will be compared between the two groups.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses complete due to early termination.
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.
Hide Description 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.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses complete due to early termination.
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Timing of First Day of Ambulation.
Hide Description The timing of the first day of ambulation will be compared between the two groups.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses complete due to early termination.
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Distance Ambulated
Hide Description The distance ambulated will be compared between the two groups.
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses complete due to early termination.
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Hospital Stay
Hide Description Length of hospital stay will be compared between the two groups.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses complete due to early termination.
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description:

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PO Acetaminophen IV Acetaminophen
Hide Arm/Group Description

1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.

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.

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

All-Cause Mortality
PO Acetaminophen IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
PO Acetaminophen IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PO Acetaminophen IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Early termination due to difficulty enrolling patient population and limitations due to timing required to consent.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrea Mantel
Organization: Spectrum Health
Phone: 616-486-2051
EMail: andrea.mantel@spectrumhealth.org
Layout table for additonal information
Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02774148    
Other Study ID Numbers: 2016-225
First Submitted: May 9, 2016
First Posted: May 17, 2016
Results First Submitted: January 11, 2018
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018