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NCT02351700 · OUTCOME

Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups

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
MEAN
Unit
dose
Interval / dispersion
Standard Deviation
Time frame
until discharge from hospital, an expected stay of 2 days

What was measured

Use of antiemetics in first 48 hours after surgery

Analysis population: all participants enrolled with the intent to treat

Groups in this outcome

Opioid-sparing Group

Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV Caldolor (IV Ibuprofen): Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively.

Standard Treatment Group

IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV Ibuprofen placebo: Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively.

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 dose · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Opioid-sparing Group9.89.1Not reportedNot reportedNot reported
Standard Treatment Group10.16.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.1
        value
        9.8
      2. group Id
        OG001
        spread
        6.6
        value
        10.1
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      34
    units
    Participants
description
Use of antiemetics in first 48 hours after surgery
dispersion Type
Standard Deviation
groups
  1. description
    Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV Caldolor (IV Ibuprofen): Compare addition of IV Caldolor (IV ibuprofen) intraoperatively and postoperatively against IV ibuprofen placebo added intraoperatively and postoperatively.
    id
    OG000
    title
    Opioid-sparing Group
  2. description
    IV Caldolor placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV Ibuprofen placebo: Compare addition of IV ibuprofen placebo intraoperatively and postoperatively against IV Caldolor (IV ibuprofen) added intraoperatively and postoperatively.
    id
    OG001
    title
    Standard Treatment Group
param Type
MEAN
population Description
all participants enrolled with the intent to treat
reporting Status
POSTED
time Frame
until discharge from hospital, an expected stay of 2 days
title
Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups
type
OTHER_PRE_SPECIFIED
unit Of Measure
dose

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

Preserved source evidence · Not medical advice