TriangleNCT02351700 · STUDY IN CONTEXT
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Total hospital costs for patients in IV ibuprofen arm compared to IV placebo arm
patients with one or more bowel movement(s) in the first 48 hours after surgery
Length of hospital stay from time of surgery to time of discharge.
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.
Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation
Epistaxis, potentially related to IV ibuprofen, will be compared between two groups
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- trial label
- Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0003
- source section id
- NCT02351700-om-0003
- source outcome index
- 3
- endpoint
- Total Cost of Hospital Charges Compared Between Two Arms
- endpoint definition
- Total hospital costs for patients in IV ibuprofen arm compared to IV placebo arm
- time origin
- until discharge from hospital, an expected stay of 2 days
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0004
- source section id
- NCT02351700-om-0004
- source outcome index
- 4
- endpoint
- The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups
- endpoint definition
- patients with one or more bowel movement(s) in the first 48 hours after surgery
- time origin
- until discharge from hospital, an expected stay of 2 days
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- all patients enrolled with intent to treat
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0005
- source section id
- NCT02351700-om-0005
- source outcome index
- 5
- endpoint
- Length of Stay in Hospital Compared Between Two Arms
- endpoint definition
- Length of hospital stay from time of surgery to time of discharge.
- time origin
- until discharge from hospital, an expected stay of 2 days
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- all participants enrolled with the intent to treat
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0000
- source section id
- NCT02351700-om-0000
- source outcome index
- 0
- endpoint
- Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)
- endpoint definition
- 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.
- time origin
- mean pain score over 48 hours
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants enrolled with the intent to treat.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0001
- source section id
- NCT02351700-om-0001
- source outcome index
- 1
- endpoint
- Breakthrough Narcotic Requirement
- endpoint definition
- Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation
- time origin
- until discharge from hospital, an expected stay of 2 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants enrolled with the intent to treat.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0002
- source section id
- NCT02351700-om-0002
- source outcome index
- 2
- endpoint
- Other Adverse Events
- endpoint definition
- Epistaxis, potentially related to IV ibuprofen, will be compared between two groups
- time origin
- until discharge from hospital, an expected stay of 2 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Opioid-sparing Group
- regimen
- 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.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Standard Treatment Group
- regimen
- 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.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Opioid-sparing Group
- regimen
- 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.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Standard Treatment Group
- regimen
- 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.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Opioid Sparing Group
- regimen
- IV Caldolor (ibuprofen) 800 mg every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Standard Treatment Group
- regimen
- IV placebo every 8 hours initiated during surgery and oral acetaminophen 1000 mg every 6 hours plus rescue opiates as needed
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Opioid-sparing Group
- regimen
- 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.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Standard Treatment Group
- regimen
- 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.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Opioid-sparing Group
- regimen
- 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.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Standard Treatment Group
- regimen
- 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.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02351700-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- harm key
- EG000
- source section id
- NCT02351700-ae
- event group key
- EG000
- event group label
- Opioid-sparing Group
- serious affected
- 0
- serious at risk
- 28
- other affected
- 2
- other at risk
- 28
- frequency threshold
- 0
- collection period
- surgery date until hospital discharge (average of 2 days)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-pituitary-tumors
- nct id
- NCT02351700
- harm key
- EG001
- source section id
- NCT02351700-ae
- event group key
- EG001
- event group label
- Standard Treatment Group
- serious affected
- 2
- serious at risk
- 34
- other affected
- 0
- other at risk
- 34
- frequency threshold
- 0
- collection period
- surgery date until hospital discharge (average of 2 days)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice