At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 62 enrolled
Drug / intervention
IV Caldolor +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
St. Joseph's Hospital and Medical Center, Phoenix·interventional·Posted Jan 30, 2015·Updated Oct 21, 2021
In Brief
A Phase 4 clinical trial evaluating IV Caldolor and IV Placebo for Pituitary Tumor and Pain. Completed, enrolled 62 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPituitary Tumor, Pain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartFeb 2015
Primary CompletionMar 2016
Study CompletionApr 2016
TodayJul 2026
First PostedJan 30, 2015
Enrollment StartFeb 1, 2015
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.4 years ago
Interventions
IV Caldolordrug
IV Caldolor (IV ibuprofen) intraoperatively and postoperatively
IV Placebodrug
IV Placebo intraoperatively and postoperatively