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Phase 4 N=62 Randomized Double-blind Supportive Care

Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Pituitary Tumor · Pain

Bottom Line

View on ClinicalTrials.gov: NCT02351700 ↗
Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Oct 2021
Primary outcome: Primary: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) — 1.7; 2.8 0-10 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
IV Caldolor (Drug); IV Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Primary completion
Mar 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)		 1.7; 2.8 —
SECONDARY
Breakthrough Narcotic Requirement		 26.3; 62.5 —
SECONDARY
Other Adverse Events		 0; 2 —

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.

Eligibility Criteria

Inclusion Criteria

  • Adult patient undergoing ENTS surgery for resection of pituitary tumor.
  • Adults >18 years and 19 and 2.0
  • Allergy or intolerance to acetaminophen, ibuprofen, or opioids
  • Pre-operative opioid tolerance, dependence, or abuse
  • Anaphylaxis to opioids
  • History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery
  • Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range, defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin> 3x upper limit of normal range
  • Subject unwilling or unable to sign informed consent for the study
  • Pregnancy
  • Incarcerated patients
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02351700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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