Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | July 2011 |
| End Date: | July 2015 |
Analgesia Efficacy of Repeated Doses of Intravenous Acetaminophen (Paracetamol) in the Pediatric Spinal Fusion Population
This is a prospective, randomized, double-blinded, placebo controlled trial Potential
subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal
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).
subjects will be identified from the Pre-Surgical Anesthesia Clinic visit. Parents/legal
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).
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.
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.
Inclusion Criteria:
Subjects 10-18 years who are status post anterior or posterior spine fusion surgery
Exclusion Criteria:
1. All patients requiring mechanical ventilation post-operatively, continuous infusions
of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)
2. Patients with hepatic dysfunction
3. Patients with chronic opiate requirements
4. Pregnant or lactating females
5. Patients placed on opiates other than morphine or hydromorphone
6. Patients with opiate or acetaminophen allergies
7. Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)
8. Patients who receive intrathecal opiates
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