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NCT02351700 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Standard Treatment Group
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        34
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        34
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomized 1:1 ratio with blinded treatment assignment. Used a computer-generated list from random.org.
recruitment Details
Adult patients undergoing endonasal transsphenoidal surgery for pituitary adenoma. Potential patients were identified in the Pituitary Clinic at Barrow Neurological Institute.
Complete source fields
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
    FG000
    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
    FG001
    title
    Standard Treatment Group
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        34
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        34
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Randomized 1:1 ratio with blinded treatment assignment. Used a computer-generated list from random.org.
recruitment Details
Adult patients undergoing endonasal transsphenoidal surgery for pituitary adenoma. Potential patients were identified in the Pituitary Clinic at Barrow Neurological Institute.

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

Preserved source evidence · Not medical advice