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Trial record 52 of 326 for:    clonidine

Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?

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ClinicalTrials.gov Identifier: NCT02361476
Recruitment Status : Completed
First Posted : February 11, 2015
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mogens Ydemann, Rigshospitalet, Denmark

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Psychomotor Agitation
Interventions Drug: Clonidine
Drug: Placebo
Enrollment 379
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Placebo
Hide Arm/Group Description

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Period Title: Overall Study
Started 191 188
Completed 191 188
Not Completed 0 0
Arm/Group Title Intervention Placebo Total
Hide Arm/Group Description

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Total of all reporting groups
Overall Number of Baseline Participants 191 188 379
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
< 2 years Number Analyzed 191 participants 188 participants 379 participants
46 43 89
>/= 2 years Number Analyzed 191 participants 188 participants 379 participants
145 145 290
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants 188 participants 379 participants
Female
37
  19.4%
38
  20.2%
75
  19.8%
Male
154
  80.6%
150
  79.8%
304
  80.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 191 participants 188 participants 379 participants
191 188 379
1.Primary Outcome
Title Postoperative Agitation
Hide Description Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
9 were excluded in the primary outcome due to missing data points
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Overall Number of Participants Analyzed 187 183
Measure Type: Number
Unit of Measure: participants with agitation
46 86
2.Secondary Outcome
Title Fentanyl and Morphine Requirements
Hide Description Amount used
Time Frame Recorded during the stay in the postoperative recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Overall Number of Participants Analyzed 191 188
Mean (Standard Deviation)
Unit of Measure: mg morphine equivalents
0.46  (0.94) 0.7  (1.11)
3.Secondary Outcome
Title Pain Assessment
Hide Description

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

Time Frame recovery room - hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Overall Number of Participants Analyzed 191 188
Mean (Standard Deviation)
Unit of Measure: Pain Score
1.57  (2.62) 2.45  (3.1)
4.Secondary Outcome
Title First Administration of Fentanyl or Morphine
Hide Description Time to administration
Time Frame recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Overall Number of Participants Analyzed 191 188
Median (Standard Deviation)
Unit of Measure: MEDIAN time (min) to administration
105  (57) 60  (46)
5.Secondary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame from intervention to discharge from the recovery room
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Placebo
Hide Arm/Group Description:

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

Overall Number of Participants Analyzed 191 188
Measure Type: Number
Unit of Measure: participants
adverse events 0 5
serious adverse events 2 2
Treated for low blood pressure 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Placebo
Hide Arm/Group Description

Clonidine : injection og 3 micg/kg IV during the operation.

Clonidine: Injection - during surgery

Placebo : injection og equal amount of NaCl IV during the operation.

Placebo: Injection - during surgery

All-Cause Mortality
Intervention Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/191 (0.00%)      0/188 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/191 (1.05%)      2/188 (1.06%)    
Gastrointestinal disorders     
PONV  [1]  1/191 (0.52%)  1 0/188 (0.00%)  0
General disorders     
Late arrival in the postoperative care unit  [1]  0/191 (0.00%)  0 1/188 (0.53%)  1
Pale and not drinking and eating  [1]  1/191 (0.52%)  1 0/188 (0.00%)  0
Surgical and medical procedures     
Re-bleeding  [1]  0/191 (0.00%)  0 1/188 (0.53%)  1
Indicates events were collected by systematic assessment
[1]
events leading to admission
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/191 (0.00%)      5/188 (2.66%)    
General disorders     
Opioid-related side-effects   0/191 (0.00%)  0 3/188 (1.60%)  3
Laryngeal spasm   0/191 (0.00%)  0 1/188 (0.53%)  1
Prolonged anaesthesia   0/191 (0.00%)  0 1/188 (0.53%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mogens Ydemann, MD
Organization: Rigshospitalet
Phone: +45 35455620
EMail: mogens@ydemann.dk
Layout table for additonal information
Responsible Party: Mogens Ydemann, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02361476     History of Changes
Other Study ID Numbers: H - 2 - 2014 - 072
First Submitted: February 1, 2015
First Posted: February 11, 2015
Results First Submitted: November 22, 2017
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019