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NCT02351700 · OUTCOME

Other Adverse Events

Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors · Source last updated 2021-10-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
until discharge from hospital, an expected stay of 2 days

What was measured

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

Groups in this outcome

Opioid Sparing Group

IV Caldolor (ibuprofen) 800 mg every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed

Standard Treatment Group

IV placebo every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Opioid Sparing Group28
Standard Treatment Group34

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Opioid Sparing Group0Not reportedNot reportedNot reportedNot reported
Standard Treatment Group2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      34
    units
    Participants
description
Epistaxis, potentially related to IV ibuprofen, will be compared between two groups
groups
  1. description
    IV Caldolor (ibuprofen) 800 mg every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed
    id
    OG000
    title
    Opioid Sparing Group
  2. description
    IV placebo every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed
    id
    OG001
    title
    Standard Treatment Group
param Type
NUMBER
reporting Status
POSTED
time Frame
until discharge from hospital, an expected stay of 2 days
title
Other Adverse Events
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice