Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients

NCT01394718 | Completed Phase 3 Results

• 1 other identifier: 11-08095
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pain, Postoperative

Keywords

analgesic adjunct; acetaminophen; spine fusion surgery; opiate reduction; pain management after elective surgical operation

Outcome Measures

Primary Outcomes (1)

• Total Opiate Requirement

  Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents.

  24 hours

Secondary Outcomes (3)

• Average Pain Score

  24 hours

• Average Nausea Score

  24 hours

• Average Pruritus Score

  24 hours

Study Arms (2)

Saline Placebo

PLACEBO COMPARATOR

Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Other: Placebo

Intravenous Acetaminophen

EXPERIMENTAL

Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Drug: Intravenous Acetaminophen

Interventions

Intravenous Acetaminophen DRUG

Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.

Intravenous Acetaminophen

Placebo OTHER

Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Saline Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects 10-18 years who are status post anterior or posterior spine fusion surgery

You may not qualify if:

• All patients requiring mechanical ventilation post-operatively, continuous infusions of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)
• Patients with hepatic dysfunction
• Patients with chronic opiate requirements
• Pregnant or lactating females
• Patients placed on opiates other than morphine or hydromorphone
• Patients with opiate or acetaminophen allergies
• Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)
• Patients who receive intrathecal opiates

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

This is a single center study with subjects confined to a single surgical procedure with a small sample size, possibly limiting generalizability of results.

Results Point of Contact

• Title: Athena Zuppa, MD, MSCE
• Organization: Children's Hospital of Philadelphia

zuppa@email.chop.edu

267-426-7359

Study Officials

• Athena Zuppa, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 14, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2015
• Last Updated: April 18, 2016
• Results First Posted: April 18, 2016

Record last verified: 2016-03

Locations

US (1)