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Intravenous Ibuprofen for Laparoscopic Bariatric Surgery

NCT01707251 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-09-03

No results posted yet for this study

Summary

Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.

Conditions

Interventions

DRUG

Intravenous Ibuprofen

800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).

DRUG

Saline

Placebo control

Sponsors & Collaborators

  • Cumberland Pharmaceuticals

    collaborator INDUSTRY

  • Sagatech Electronics Inc, Alberta, Canada

    collaborator UNKNOWN

  • Jacobi Medical Center

    lead OTHER

Principal Investigators

  • Mindaugas Pranevicius, MD · Jacobi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01707251 on ClinicalTrials.gov