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The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. 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 patient/nurse controlled analgesia (PCA) to oral pain medications.
To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission.
Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV tylenol | Experimental | 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. |
|
| No IV tylenol | Active Comparator | Same as above without IV tylenol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV tylenol | Drug | IV tylenol given scheduled in addition to standard PCA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Until PCA Discontinued After the Operation | 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. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Duration of Hospital Stay | The investigators will measure postoperative time to discharge | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn D St. Peter, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Until PCA Discontinued After the Operation | 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. | Posted | Mean | 95% Confidence Interval | hours | 4 days |
|
Duration of length of stay up to one week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shawn St. Peter | Children's Mercy Hospital | 816-234-3000 | 3575 | sspeter@cmh.edu |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| No IV tylenol | Drug | No additional IV Tylenol given |
|
| Ketorolac | Drug | both groups receive as part of our standard postop pain protocol after all operations |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| Secondary | Postoperative Duration of Hospital Stay | The investigators will measure postoperative time to discharge | Posted | Median | Inter-Quartile Range | days | 1 week |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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 | 0 | 43 | 0 | 43 | 0 | 43 |
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |