Trial Outcomes & Findings for Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain (NCT NCT02746263)

Last Updated: 2019-11-19

Results Overview

Participants rate intensity of their pain on a Numerical Pain Scale (NPS) from 0-10, wherein 0=no pain (better) and 10=most intense pain (worse). The highest possible score is 10.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

18 hours

Results posted on

2019-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	IV Acetaminophen/Morphine IV acetaminophen 1000 mg every 6 hours over 18 hours IV acetaminophen Morphine: Patient controlled analgesia	Oral Acetaminophen/Morphine Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours Oral acetaminophen Morphine: Patient controlled analgesia
Overall Study STARTED	0	1
Overall Study Per Protocol Analysis Set	0	0
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 18 hours

Population: Per Protocol Analysis Set - The single participant enrolled was in violation of the protocol, leading to unreliable or uninterpretable data.

Participants rate intensity of their pain on a Numerical Pain Scale (NPS) from 0-10, wherein 0=no pain (better) and 10=most intense pain (worse). The highest possible score is 10.

Outcome measures

Outcome data not reported

Adverse Events

IV Acetaminophen/Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Acetaminophen/Morphine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IV Acetaminophen/Morphine IV acetaminophen 1000 mg every 6 hours over 18 hours IV acetaminophen Morphine: Patient controlled analgesia	Oral Acetaminophen/Morphine n=1 participants at risk Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours Oral acetaminophen Morphine: Patient controlled analgesia
Blood and lymphatic system disorders Acute blood loss anemia	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Respiratory, thoracic and mediastinal disorders Diffuse bronchial wall thickening	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Blood and lymphatic system disorders Intermittent thrombocytopenia	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Blood and lymphatic system disorders Intermittent leucocytosis	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Cardiac disorders Persistent sinus tachycardia	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
General disorders Postoperative pain	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Endocrine disorders Stress hyperglycemia	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).
Endocrine disorders Suspicion of adrenal insufficiency	— 0/0 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).	100.0% 1/1 • Number of events 1 • 9 days Number of participants at risk for All-Cause Mortality, Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) are all 0 for the intravenous acetaminophen arm because no participants were enrolled into that arm. All non-serious AEs are reported for the single subject enrolled into the oral acetaminophen arm (including opioid AEs).

Additional Information

Medical Information Call Center

Mallinckrodt Pharmaceuticals

Phone: 800-556-3314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place