Trial Outcomes & Findings for Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population (NCT NCT01477892)

NCT ID: NCT01477892

Last Updated: 2013-09-13

Results Overview

P0-P2 units on a scale ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2) PIPP (preterm infant pain profile) * min 0 \~ max 21 * higher pain scale on higher score

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop
• Results posted on: 2013-09-13

Participant Flow

This noninferiority randomized, double-blind, controlled trial was conducted at the NICU of Seoul National University Children's Hospital and Ajou University Hospital between November 2011 and April 2012

Participant milestones

Measure	High Dose Remifentanil continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Low Dose Remifentanil continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Overall Study STARTED	7	7
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	High Dose Remifentanil continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Low Dose Remifentanil continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population

Baseline characteristics by cohort

Measure	High Dose Remifentanil n=7 Participants continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Low Dose Remifentanil n=5 Participants continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Korea, Republic of	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Gestatonal age	183 days FULL_RANGE 0.03 • n=5 Participants	181 days FULL_RANGE 0.03 • n=7 Participants	182 days FULL_RANGE 0.03 • n=5 Participants

PRIMARY outcome

Timeframe: first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop

P0-P2 units on a scale

; changes in PIPP from baseline (P0) to procedure (needle puncture, P2)

PIPP (preterm infant pain profile)

• min 0 ~ max 21
• higher pain scale on higher score

Outcome measures

Measure	High Dose Remifentanil n=7 Participants continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Low Dose Remifentanil n=5 Participants continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Premature Infant Pain Profile	-0.60 units on a scale Standard Deviation 5.32	1.43 units on a scale Standard Deviation 3.10

SECONDARY outcome

Timeframe: during and after 10min of remifentanil continous infusion

bradycardia, hypotension, apnea, desaturation

Outcome measures

Measure	High Dose Remifentanil n=7 Participants continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Low Dose Remifentanil n=5 Participants continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Adverse Reaction Apnea	3 participants	0 participants
Adverse Reaction Bradycardia	1 participants	0 participants
Adverse Reaction Hypotension	0 participants	0 participants

Adverse Events

High Dose Remifentanil

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Low Dose Remifentanil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High Dose Remifentanil n=7 participants at risk continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control	Low Dose Remifentanil n=5 participants at risk continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Respiratory, thoracic and mediastinal disorders apnea	42.9% 3/7 • Number of events 3 • during remifentanil infusion	0.00% 0/5 • during remifentanil infusion
Cardiac disorders bradycardia	14.3% 1/7 • Number of events 1 • during remifentanil infusion	0.00% 0/5 • during remifentanil infusion

Additional Information

Pf. Han-suk Kim

Seoul National University Hospital

Phone: +82-2-2072-0647

Email: kimhans@snu.ac.kr

Results disclosure agreements

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