NCT02351700 · ADVERSE EVENTS

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: surgery date until hospital discharge (average of 2 days)
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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 2-4 mg 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 0.5-2 mg every 2 hours and oral 2-4 mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV Caldolor (Ibuprofen): Compare addition of IV Caldolor (ibuprofen) intraoperatively and postoperatively against IV placebo added intraoperatively and postoperatively.	0 / 28	2 / 28	0 / 28
Standard Treatment Group IV 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 0.5-2 mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV placebo: Compare addition of IV placebo intraoperatively and postoperatively against IV Caldolor (ibuprofen) added intraoperatively and postoperatively.	2 / 34	0 / 34	0 / 34

Group identifiers: EG000: Opioid-sparing Group · EG001: Standard Treatment Group

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
A disorder characterized by bleeding from the nose.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
2
num At Risk
34
num Events
2
term
Epistaxis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
elevated level of potassium (K+) in the blood serum. Normal potassium levels are between 3.5 and 5.0 mmol/L (3.5 and 5.0 mEq/L) with levels above 5.5 mmol/L defined as hyperkalemia.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
34
num Events
0
term
hyperkalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
I.V. fluid or medications leak into the surrounding tissue.
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
34
num Events
0
term
burning at IV site

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
28
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 2-4 mg 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 0.5-2 mg every 2 hours and oral 2-4 mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV Caldolor (Ibuprofen): Compare addition of IV Caldolor (ibuprofen) intraoperatively and postoperatively against IV placebo added intraoperatively and postoperatively.
id
EG000
other Num Affected
2
other Num At Risk
28
serious Num Affected
0
serious Num At Risk
28
title
Opioid-sparing Group
deaths Num Affected
0
deaths Num At Risk
34
description
IV 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 0.5-2 mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance. IV placebo: Compare addition of IV placebo intraoperatively and postoperatively against IV Caldolor (ibuprofen) added intraoperatively and postoperatively.
id
EG001
other Num Affected
0
other Num At Risk
34
serious Num Affected
2
serious Num At Risk
34
title
Standard Treatment Group

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
elevated level of potassium (K+) in the blood serum. Normal potassium levels are between 3.5 and 5.0 mmol/L (3.5 and 5.0 mEq/L) with levels above 5.5 mmol/L defined as hyperkalemia.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
34
num Events
0
term
hyperkalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
I.V. fluid or medications leak into the surrounding tissue.
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
group Id
EG001
num Affected
0
num At Risk
34
num Events
0
term
burning at IV site

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
A disorder characterized by bleeding from the nose.
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE
stats
group Id
EG000
num Affected
0
num At Risk
28
num Events
0
group Id
EG001
num Affected
2
num At Risk
34
num Events
2
term
Epistaxis

time Frame

surgery date until hospital discharge (average of 2 days)

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Preserved source evidence · Not medical advice