Trial Outcomes & Findings for The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis (NCT NCT02881996)

NCT ID: NCT02881996

Last Updated: 2021-01-12

Results Overview

The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2021-01-12

Participant Flow

Participant milestones

Measure	IV Tylenol Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	No IV Tylenol Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
Overall Study STARTED	45	45
Overall Study COMPLETED	39	43
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	IV Tylenol n=39 Participants Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	No IV Tylenol n=43 Participants Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=39 Participants	43 Participants n=43 Participants	82 Participants n=82 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants	0 Participants n=43 Participants	0 Participants n=82 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=43 Participants	0 Participants n=82 Participants
Age, Continuous	10.9 years n=39 Participants	9.6 years n=43 Participants	10.25 years n=82 Participants
Sex: Female, Male Female	14 Participants n=39 Participants	13 Participants n=43 Participants	27 Participants n=82 Participants
Sex: Female, Male Male	25 Participants n=39 Participants	30 Participants n=43 Participants	55 Participants n=82 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	39 participants n=39 Participants	43 participants n=43 Participants	82 participants n=82 Participants

PRIMARY outcome

Timeframe: 4 days

The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications.

Outcome measures

Measure	IV Tylenol n=39 Participants Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	No IV Tylenol n=43 Participants Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
Time Until PCA Discontinued After the Operation	76.4 hours Interval 43.9 to 108.9	86.7 hours Interval 37.4 to 136.0

SECONDARY outcome

Timeframe: 1 week

The investigators will measure postoperative time to discharge

Outcome measures

Measure	IV Tylenol n=39 Participants Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers. IV tylenol: IV tylenol given scheduled in addition to standard PCA Ketorolac: both groups receive as part of our standard postop pain protocol after all operations	No IV Tylenol n=43 Participants Same as above without IV tylenol. No IV tylenol: No additional IV Tylenol given Ketorolac: both groups receive as part of our standard postop pain protocol after all operations
Postoperative Duration of Hospital Stay	3.9 days Interval 3.1 to 5.9	4.5 days Interval 3.1 to 6.1

Adverse Events

IV Tylenol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No IV Tylenol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shawn St. Peter

Children's Mercy Hospital

Phone: 816-234-3000

Email: sspeter@cmh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place