Trial Outcomes & Findings for Does Intraoperative Clonidine Reduce Post Operative Agitation in Children? (NCT NCT02361476)

NCT ID: NCT02361476

Last Updated: 2019-02-11

Results Overview

Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 379 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2019-02-11

Participant Flow

Participant milestones

Measure	Intervention Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
Overall Study STARTED	191	188
Overall Study COMPLETED	191	188
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=191 Participants Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 Participants Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery	Total n=379 Participants Total of all reporting groups
Age, Customized < 2 years	46 participants n=191 Participants	43 participants n=188 Participants	89 participants n=379 Participants
Age, Customized >/= 2 years	145 participants n=191 Participants	145 participants n=188 Participants	290 participants n=379 Participants
Sex: Female, Male Female	37 Participants n=191 Participants	38 Participants n=188 Participants	75 Participants n=379 Participants
Sex: Female, Male Male	154 Participants n=191 Participants	150 Participants n=188 Participants	304 Participants n=379 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Denmark	191 participants n=191 Participants	188 participants n=188 Participants	379 participants n=379 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 9 were excluded in the primary outcome due to missing data points

Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated

Outcome measures

Measure	Intervention n=187 Participants Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=183 Participants Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
Postoperative Agitation	46 participants with agitation	86 participants with agitation

SECONDARY outcome

Timeframe: Recorded during the stay in the postoperative recovery room

Amount used

Outcome measures

Measure	Intervention n=191 Participants Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 Participants Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
Fentanyl and Morphine Requirements	0.46 mg morphine equivalents Standard Deviation 0.94	0.7 mg morphine equivalents Standard Deviation 1.11

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention n=191 Participants Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 Participants Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
Pain Assessment	1.57 Pain Score Standard Deviation 2.62	2.45 Pain Score Standard Deviation 3.1

SECONDARY outcome

Timeframe: recovery room

Time to administration

Outcome measures

Measure	Intervention n=191 Participants Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 Participants Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
First Administration of Fentanyl or Morphine	105 MEDIAN time (min) to administration Standard Deviation 57	60 MEDIAN time (min) to administration Standard Deviation 46

SECONDARY outcome

Timeframe: from intervention to discharge from the recovery room

Outcome measures

Measure	Intervention n=191 Participants Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 Participants Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
Adverse Events adverse events	0 participants	5 participants
Adverse Events serious adverse events	2 participants	2 participants
Adverse Events Treated for low blood pressure	0 participants	0 participants

Adverse Events

Intervention

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=191 participants at risk Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 participants at risk Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
Surgical and medical procedures Re-bleeding	0.00% 0/191	0.53% 1/188 • Number of events 1
General disorders Late arrival in the postoperative care unit	0.00% 0/191	0.53% 1/188 • Number of events 1
General disorders Pale and not drinking and eating	0.52% 1/191 • Number of events 1	0.00% 0/188
Gastrointestinal disorders PONV	0.52% 1/191 • Number of events 1	0.00% 0/188

Other adverse events

Measure	Intervention n=191 participants at risk Clonidine : injection og 3 micg/kg IV during the operation. Clonidine: Injection - during surgery	Placebo n=188 participants at risk Placebo : injection og equal amount of NaCl IV during the operation. Placebo: Injection - during surgery
General disorders Opioid-related side-effects	0.00% 0/191	1.6% 3/188 • Number of events 3
General disorders Laryngeal spasm	0.00% 0/191	0.53% 1/188 • Number of events 1
General disorders Prolonged anaesthesia	0.00% 0/191	0.53% 1/188 • Number of events 1

Additional Information

Mogens Ydemann, MD

Rigshospitalet

Phone: +45 35455620

Email: mogens@ydemann.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place