Infant, Preterm
Conditions
Brief summary
The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.
Interventions
non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
Sponsors
Ajou University School of Medicine
Severance Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* preterm infants mechanically ventilated * requiring peripherally induced central catheterization * with informed consent of their parents
Exclusion criteria
* major congenital anomalies * cardiopulmonary instability * use of sedative, antiepileptic drugs or anesthetic drugs * grade III or IV intraventricular hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premature Infant Pain Profile | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Reaction | during and after 10min of remifentanil continous infusion | bradycardia, hypotension, apnea, desaturation |
Countries
South Korea
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 5 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | High Dose Remifentanil | Low Dose Remifentanil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Gestatonal age | 183 days FULL_RANGE 0.03 | 181 days FULL_RANGE 0.03 | 182 days FULL_RANGE 0.03 |
| Region of Enrollment Korea, Republic of | 7 participants | 5 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 |
Outcome results
Primary
Premature Infant Pain Profile
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
Time frame: first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Remifentanil | Premature Infant Pain Profile | -0.60 units on a scale | Standard Deviation 5.32 |
| Low Dose Remifentanil | Premature Infant Pain Profile | 1.43 units on a scale | Standard Deviation 3.1 |
Secondary
Adverse Reaction
bradycardia, hypotension, apnea, desaturation
Time frame: during and after 10min of remifentanil continous infusion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose Remifentanil | Adverse Reaction | Apnea | 3 participants |
| High Dose Remifentanil | Adverse Reaction | Bradycardia | 1 participants |
| High Dose Remifentanil | Adverse Reaction | Hypotension | 0 participants |
| Low Dose Remifentanil | Adverse Reaction | Apnea | 0 participants |
| Low Dose Remifentanil | Adverse Reaction | Bradycardia | 0 participants |
| Low Dose Remifentanil | Adverse Reaction | Hypotension | 0 participants |