Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01394718
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2011-07-13
Brief Title:
Analgesic Efficacy of Repeated Doses of Intravenous IV Acetaminophen in Post-operative Pediatric Spine Fusion Patients
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Analgesia Efficacy of Repeated Doses of Intravenous Acetaminophen Paracetamol in the Pediatric Spinal Fusion Population
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IV APAP SF
Brief Summary:
This is a prospective randomized double-blinded placebo controlled trial Potential subjects will be identified from the Pre-Surgical Anesthesia Clinic visit Parentslegal guardians will be approached about study participation at the Anesthesia outpatient pre-visit Attending Anesthesiologist will receive e-mail notification about potential subject participation the day before the scheduled surgery Study lab hepatic function panel will be collected as soon as possible after anesthesia induction by anesthesia Results will be reviewed by study team member and study drug will be ordered by study team if patient does not meet exclusion criteria Study drug IV acetaminophen or placebo will be administered at the time of skin closure by anesthesia on completion of the surgical procedure after randomization Study drug will be administered every 6 hours for 2 days Subjects will continue to receive standard of care with patient controlled analgesia PCA opiate therapy morphine or hydromorphone for analgesia as per the Pain Management Service Pain scores opiate morphine equivalent administered requirements for treatment of opiate related side effects treatment for nausea and itching and certain post-operative characteristics will be measured for up to 4 days post-operatively time to mobilization time to diet advancement time to discharge
Detailed Description:
An ideal drug as an opiate-sparing analgesic adjunct acetaminophen unlike some other drugs is platelet function sparing and thus particularly useful in the post-operative orthopedic patient population In part because of its well established safety profile as well as minimal drug interactions acetaminophen is considered a cornerstone of a multimodal analgesic approach Several studies have described the clinically significant beneficial effects of a multimodal drug approach to analgesia citing improved pain control and a shorter recovery time Reduced adverse events and improved pain control with multimodal analgesia drug approaches may result in shorter hospitalizations improved recovery and function and reduced health care costs Opiate therapy while effective analgesia is associated with a variety of potential adverse side effects including pruritus nausea emesis ileus respiratory depression tolerance addiction and sedation These adverse effects may limit post-operative mobility postpone return of bowel function cause feeding intolerance prolong hospitalization and postpone post-operative recovery
While oral acetaminophen is useful as an opiate-sparing therapy the oral route of drug administration may not be feasible in the early post-operative period Enteral drug absorption in the initial post-operative period may be erratic with negative impacts on therapeutic effect Intravenous acetaminophen may a particularly useful analgesic in these circumstances At present there are no pediatric studies in the United States examining the efficacy of multiple- dose IV acetaminophen in the post-operative surgical population This study will compare analgesic efficacy nausea and pruritus scores time to recovery and length of hospital stay in two subject groups who are status post spine fusion surgery those who receive schedule IV acetaminophen and opiate for 48 hours and those who are treated with standard opiate therapy without IV acetaminophen
While oral acetaminophen is useful as an opiate-sparing therapy the oral route of drug administration may not be feasible in the early post-operative period Enteral drug absorption in the initial post-operative period may be erratic with negative impacts on therapeutic effect Intravenous acetaminophen may a particularly useful analgesic in these circumstances At present there are no pediatric studies in the United States examining the efficacy of multiple- dose IV acetaminophen in the post-operative surgical population This study will compare analgesic efficacy nausea and pruritus scores time to recovery and length of hospital stay in two subject groups who are status post spine fusion surgery those who receive schedule IV acetaminophen and opiate for 48 hours and those who are treated with standard opiate therapy without IV acetaminophen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None