Trial · NCT00221338

Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain

NCT00221338, Phase 3, Completed, University of California, San Francisco; results first posted 2020-09-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain. Trials, record NCT00221338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00221338

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain
NCT number: NCT00221338
Status: Completed
Phases: Phase 3
Enrollment: 750 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Postoperative Delirium, Postoperative Pain, Opioid Use, Hospital Length of Stay
Interventions: Gabapentin
First posted: 2005-09-22
Last updated: 2020-09-10
Results first posted: 2020-09-10

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Postoperative Delirium by Study Group	postoperative days 1, 2 and 3	Number of subjects who developed postoperative delirium, as measured by the Confusion Assessment Method, a validated tool for assessing delirium based on DSM-III-R, on any of the first three postoperative days.
Secondary	Median Postoperative Opioid Doses Across Study Follow up Period	Study follow up period: postoperative days 1, 2 and 3	Postoperative intravenous opioid doses converted to morphine equivalents. Median derived from total opioid doses on first, second and third postoperative days.
Secondary	Hospital Length of Stay	Typically within the first week after surgery
Secondary	Postoperative Pain Score - Postoperative Day 1	Postoperative day 1	Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).
Secondary	Postoperative Pain Score - Postoperative Day 2	Postoperative day 2	Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).
Secondary	Postoperative Pain Score - Postoperative Day 3	Postoperative day 3	Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Incidence of Postoperative Delirium by Study Group	postoperative days 1, 2 and 3	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Postoperative Opioid Doses Across Study Follow up Period	Study follow up period: postoperative days 1, 2 and 3	morphine equivalents, mg	MEDIAN
SECONDARY	Hospital Length of Stay	Typically within the first week after surgery	days	MEAN
SECONDARY	Postoperative Pain Score - Postoperative Day 1	Postoperative day 1	score on a scale	MEAN
SECONDARY	Postoperative Pain Score - Postoperative Day 2	Postoperative day 2	score on a scale	MEAN
SECONDARY	Postoperative Pain Score - Postoperative Day 3	Postoperative day 3	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Incidence of Postoperative Delirium by Study Group	Gabapentin	84		Participants
Incidence of Postoperative Delirium by Study Group	Placebo	72		Participants
Median Postoperative Opioid Doses Across Study Follow up Period	Gabapentin	6.7	Inter-Quartile Range 1.3 to 20	morphine equivalents, mg
Median Postoperative Opioid Doses Across Study Follow up Period	Placebo	6.7	Inter-Quartile Range 2.7 to 24.8	morphine equivalents, mg
Hospital Length of Stay	Gabapentin	4.4	Standard Deviation 3.4	days
Hospital Length of Stay	Placebo	4.1	Standard Deviation 2.3	days
Postoperative Pain Score - Postoperative Day 1	Gabapentin	4	Standard Deviation 3	score on a scale
Postoperative Pain Score - Postoperative Day 1	Placebo	4	Standard Deviation 3	score on a scale
Postoperative Pain Score - Postoperative Day 2	Gabapentin	3	Standard Deviation 3	score on a scale
Postoperative Pain Score - Postoperative Day 2	Placebo	4	Standard Deviation 3	score on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin	374
Overall Study	STARTED	Placebo	376
Overall Study	COMPLETED	Gabapentin	350
Overall Study	COMPLETED	Placebo	347
Overall Study	NOT COMPLETED	Gabapentin	24
Overall Study	NOT COMPLETED	Placebo	29

Source ClinicalTrials.gov

Adverse events68

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Oxygen Desaturation	Respiratory, thoracic and mediastinal disorders	Gabapentin	37	350	37
other	Oxygen Desaturation	Respiratory, thoracic and mediastinal disorders	Placebo	56	347	56
other	Sedation	Nervous system disorders	Gabapentin	3	350	3
other	Sedation	Nervous system disorders	Placebo	6	347	6
other	Syncope	General disorders	Gabapentin	0	350	0
other	Syncope	General disorders	Placebo	5	347	5
other	Dysphagia	General disorders	Gabapentin	1	350	1
other	Dysphagia	General disorders	Placebo	0	347	0
other	Ileus	Gastrointestinal disorders	Gabapentin	1	350	1
other	Ileus	Gastrointestinal disorders	Placebo	1	347	1

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gabapentin	0	350
Total, all-cause mortality	Placebo	1	347
Total, other adverse events	Gabapentin	42	350
Total, other adverse events	Placebo	67	347
Total, serious adverse events	Gabapentin	31	350
Total, serious adverse events	Placebo	44	347

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16914695	RESULT	PubMed
28727581	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gabapentin vs Placebo: Incidence of Postoperative Delirium by Study Group	Trial comparisons
Gabapentin vs Placebo: deaths from any cause	Trial comparisons
Gabapentin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00221338

GET https://conductscience.org/api/trials/v1/NCT00221338/events?page=2

API reference For AI assistants