A Phase 1/2 interventional study of low dose remifentanil in Infant, Preterm, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 12 Weeks. Per ClinicalTrials.gov, last updated 2013-09-13.
Sponsored by Seoul National University Hospital · Phase 1/2, Interventional, and Supportive care
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.
2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 14 is below the median of 84 across 1,688 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
continuous infusion of remifentanil 0.1mcg/kg/min
Drug: low dose remifentanil
continuous infusion of remifentanil 0.25mcg/kg/min
Drug: 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
Also known as: high dose remifentanil
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
Adverse Reaction
bradycardia, hypotension, apnea, desaturation
Time frame: during and after 10min of remifentanil continous infusion
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
| Milestone | High Dose Remifentanil | Low Dose Remifentanil |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 5 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
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
| units on a scale | High Dose Remifentanil | Low Dose Remifentanil |
|---|---|---|
| Premature Infant Pain Profile | -0.60 ± 5.32 | 1.43 ± 3.10 |
bradycardia, hypotension, apnea, desaturation
| participants | High Dose Remifentanil | Low Dose Remifentanil |
|---|---|---|
| Apnea | 3 | 0 |
| Bradycardia | 1 | 0 |
| Hypotension | 0 | 0 |
Collected over during remifentanil infusion. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose Remifentanil | — | 0/7 (0%) | 3/7 (42.9%) |
| Low Dose Remifentanil | — | 0/5 (0%) | 0/5 (0%) |
| Event | High Dose Remifentanil | Low Dose Remifentanil |
|---|---|---|
| apneaRespiratory, thoracic and mediastinal disorders | 3/7 | 0/5 |
| bradycardiaCardiac disorders | 1/7 | 0/5 |
| Age, Categorical(Participants) | High Dose Remifentanil | Low Dose Remifentanil | Total |
|---|---|---|---|
| <=18 years | 7 | 5 | 12 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | High Dose Remifentanil | Low Dose Remifentanil | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 4 | 2 | 6 |
| Region of Enrollment(participants) | High Dose Remifentanil | Low Dose Remifentanil | Total |
|---|---|---|---|
| Korea, Republic of | 7 | 5 | 12 |
| Gestatonal age(days) | High Dose Remifentanil | Low Dose Remifentanil | Total |
|---|---|---|---|
| Median | 183 ± 0.03 | 181 ± 0.03 | 182 ± 0.03 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital