Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

St. Barnabas Medical Center

Status and phase: Unknown; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Intravenous Ibuprofen; Other: IV Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01297829

2010-11-15

Details and patient eligibility

About

Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.

The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.

Enrollment: 51 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary inguinal and/or umbilical hernia repair
• age > 18 years old

Exclusion criteria

• history of gastrointestinal bleeding
• allergy to ibuprofen
• creatinine > 1.5 mg/dL

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

IV Caldolor

Active Comparator group

Treatment:

Drug: Intravenous Ibuprofen

Placebo

Placebo Comparator group

Treatment:

Other: IV Placebo