NCT02351700

Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Completed Phase 4 Results posted Last updated 21 October 2021

What this trial tests

Phase 4 trial testing IV Caldolor in Pituitary Tumor in 62 participants. Completed in 1 April 2016.

Timeline

1 February 2015

Primary endpoint
1 March 2016

1 April 2016

Quick facts

Lead sponsor	St. Joseph's Hospital and Medical Center, Phoenix
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	62
Start date	1 February 2015
Primary completion	1 March 2016
Estimated completion	1 April 2016
Sites	1 location across United States

Drugs / interventions tested

• IV Caldolor — full drug profile →
• IV Placebo

Conditions studied

• Pituitary Tumor — all drugs for Pituitary Tumor →
• Pain — all drugs for Pain →

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Who can join

Adults 18 to 79, any sex, with Pituitary Tumor or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) Primary · mean pain score over 48 hours

Comparison of pain scores between two arms using Visual Analog Scale (VAS) for Pain. Units of measure are 0=No Pain, 1=Annoying, 2=Mild Pain, 3=Troublesome, 4=Nagging Pain, Uncomfortable, 5=Distressing, 6=Miserable, 7=Horrible, 8=Intense, Dreadful, 9=Unbearable, 10=Worst Possible Pain. Higher values represent a worse outcome. There are no subscales.

Group	Value	95% CI
Opioid-sparing Group	1.7	± 2.2
Standard Treatment Group	2.8	± 3.0

Breakthrough Narcotic Requirement Secondary · until discharge from hospital, an expected stay of 2 days

Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation

Group	Value	95% CI
Opioid-sparing Group	26.3	± 28.7
Standard Treatment Group	62.5	± 63.8

Other Adverse Events Secondary · until discharge from hospital, an expected stay of 2 days

Epistaxis, potentially related to IV ibuprofen, will be compared between two groups

Group	Value	95% CI
Opioid Sparing Group	0
Standard Treatment Group	2

The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups Secondary · until discharge from hospital, an expected stay of 2 days

patients with one or more bowel movement(s) in the first 48 hours after surgery

Group	Value	95% CI
Opioid-sparing Group	9
Standard Treatment Group	12

Length of Stay in Hospital Compared Between Two Arms Secondary · until discharge from hospital, an expected stay of 2 days

Length of hospital stay from time of surgery to time of discharge.

Group	Value	95% CI
Opioid-sparing Group	71.3	± 47.5
Standard Treatment Group	51.7	± 30.3

Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups Secondary · until discharge from hospital, an expected stay of 2 days

Use of antiemetics in first 48 hours after surgery

Group	Value	95% CI
Opioid-sparing Group	9.8	± 9.1
Standard Treatment Group	10.1	± 6.6

Adverse events — posted to ClinicalTrials.gov

Time frame: surgery date until hospital discharge (average of 2 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Opioid-sparing Group

Serious: 0/28 (0%)

Deaths: 0/28

Standard Treatment Group

Serious: 2/34 (6%)

Deaths: 0/34

Serious adverse events (1 terms)

Reaction	System	Opioid-sparing Group	Standard Treatment Group
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Opioid-sparing Group	Standard Treatment Group
hyperkalemia	Blood and lymphatic system disorders	—	—
burning at IV site	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Epistaxis.

Data from ClinicalTrials.gov NCT02351700 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drug repurposing for cancer therapy.
   Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1
2. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.
   Shepherd DM, Jahnke H, White WL, Little AS. · · 2018 · cited 28× · PMID 28298041 · DOI 10.3171/2016.10.jns161355