Trial · NCT02361476

Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

NCT02361476, Phase 4, Completed, Copenhagen University Hospital, Rigshospitalet; results first posted 2019-02-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Does Intraoperative Clonidine Reduce Post Operative Agitation in Children? Trials, record NCT02361476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02361476

On this page

Trial

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

Title: Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
NCT number: NCT02361476
Status: Completed
Phases: Phase 4
Enrollment: 379 participants, actual
Lead sponsor: Copenhagen University Hospital, Rigshospitalet
Conditions: Psychomotor Agitation
Interventions: Clonidine, Placebo
First posted: 2015-02-11
Last updated: 2019-02-11
Results first posted: 2019-02-11

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Postoperative Agitation	1 day	Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated
Secondary	Fentanyl and Morphine Requirements	Recorded during the stay in the postoperative recovery room	Amount used
Secondary	Pain Assessment	recovery room - hours	Pain score used: FLACC score = Face, Legs, Activity, Cry, Consolability Score ranges from 0 to 10 (severity increases with increasing score) Pain is FLACC score more than 3
Secondary	First Administration of Fentanyl or Morphine	recovery room	Time to administration
Secondary	Adverse Events	from intervention to discharge from the recovery room

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Postoperative Agitation	1 day	9 were excluded in the primary outcome due to missing data points	participants with agitation	NUMBER
SECONDARY	Fentanyl and Morphine Requirements	Recorded during the stay in the postoperative recovery room		mg morphine equivalents	MEAN
SECONDARY	Pain Assessment	recovery room - hours		Pain Score	MEAN
SECONDARY	First Administration of Fentanyl or Morphine	recovery room		MEDIAN time (min) to administration	MEDIAN
SECONDARY	Adverse Events	from intervention to discharge from the recovery room		participants	NUMBER

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Postoperative Agitation	Intervention		46		participants with agitation
Postoperative Agitation	Placebo		86		participants with agitation
Fentanyl and Morphine Requirements	Intervention		0.46	Standard Deviation 0.94	mg morphine equivalents
Fentanyl and Morphine Requirements	Placebo		0.7	Standard Deviation 1.11	mg morphine equivalents
Pain Assessment	Intervention		1.57	Standard Deviation 2.62	Pain Score
Pain Assessment	Placebo		2.45	Standard Deviation 3.1	Pain Score
First Administration of Fentanyl or Morphine	Intervention		105	Standard Deviation 57	MEDIAN time (min) to administration
First Administration of Fentanyl or Morphine	Placebo		60	Standard Deviation 46	MEDIAN time (min) to administration
Adverse Events	Intervention	adverse events	0		participants
Adverse Events	Placebo	adverse events	5		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention	191
Overall Study	STARTED	Placebo	188
Overall Study	COMPLETED	Intervention	191
Overall Study	COMPLETED	Placebo	188
Overall Study	NOT COMPLETED	Intervention	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events14

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	Opioid-related side-effects	General disorders	Intervention	0	191	0
other	Opioid-related side-effects	General disorders	Placebo	3	188	3
other	Laryngeal spasm	General disorders	Intervention	0	191	0
other	Laryngeal spasm	General disorders	Placebo	1	188	1
other	Prolonged anaesthesia	General disorders	Intervention	0	191	0
other	Prolonged anaesthesia	General disorders	Placebo	1	188	1
serious	Re-bleeding	Surgical and medical procedures	Intervention	0	191	0
serious	Re-bleeding	Surgical and medical procedures	Placebo	1	188	1
serious	Late arrival in the postoperative care unit	General disorders	Intervention	0	191	0
serious	Late arrival in the postoperative care unit	General disorders	Placebo	1	188	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention	0	191
Total, all-cause mortality	Placebo	0	188
Total, other adverse events	Intervention	0	191
Total, other adverse events	Placebo	5	188
Total, serious adverse events	Intervention	2	191
Total, serious adverse events	Placebo	2	188

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24727829	BACKGROUND	PubMed
27264945	DERIVED	PubMed
30169192	DERIVED	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 comparisons2

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

Comparison	Source
Intervention vs Placebo: deaths from any cause	Trial comparisons
Intervention 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/NCT02361476

GET https://conductscience.org/api/trials/v1/NCT02361476/registered

API reference For AI assistants