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Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

NCT02351700 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-10-21

Study results available
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Summary

A randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.

Conditions

  • Pituitary Tumor
  • Pain

Interventions

DRUG

IV Caldolor

IV Caldolor (IV ibuprofen) intraoperatively and postoperatively

DRUG

IV Placebo

IV Placebo intraoperatively and postoperatively

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Andrew S Little, MD · Barrow Neurosurgical Associates physician with SJHMC privileges

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2016-03-01
Completion
2016-04-01

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 NCT02351700 on ClinicalTrials.gov