Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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