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NCT06626035 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Analgesia for Cardiac Elective Surgery in Children
A Phase 3 study of Pediatric Cardiac Surgery, sponsored by Senthil Sadhasivam.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT06626035: Recruiting Phase 3 study of Pediatric Cardiac Surgery, sponsored by Senthil Sadhasivam.
NCT06626035 is a Phase 3 study of Pediatric Cardiac Surgery that is actively recruiting participants, run by Senthil Sadhasivam. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06626035, a Phase 3 study of Pediatric Cardiac Surgery, is actively recruiting participants, sponsored by Senthil Sadhasivam.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50/50 chance, like a coin flip, of being assigned to either research group.
Primary Outcome
Average postoperative pain scores within 48 hours of surgery (Numerical Rating Scale \[NRS\], or Facial expression, Leg movement, Activity, Cry, and Consolability \[FLACC\], both 0-10). Outcome will be reported based on area under the curve (AUC) as mean(SD).
Conditions Studied
Interventions
- DRUG Methadone based ERAS
- DRUG Non-methadone based group
Study Locations (1)
Pennsylvania
- UPMC Children's Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-12-17 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 3 |
What NCT06626035 shows while recruiting
NCT06626035 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Pediatric Cardiac Surgery appearing as the primary indexed condition, and to 2 interventions - of which Methadone based ERAS is the first listed.
NCT06626035 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06626035 about?
NCT06626035 is a clinical study titled "Evaluation of Analgesia for Cardiac Elective Surgery in Children". The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recove...
What is the current status of trial NCT06626035?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-12-17. Estimated completion is 2029-08-31.
What conditions does trial NCT06626035 study?
This clinical trial studies the following conditions: Pediatric Cardiac Surgery.
What interventions are being tested in trial NCT06626035?
The interventions under investigation include: Methadone based ERAS (DRUG), Non-methadone based group (DRUG).
Who is sponsoring clinical trial NCT06626035?
This trial is sponsored by Senthil Sadhasivam, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06626035 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06626035's enrollment target sits among peer trials
500 744th of 2000 higher than 1,227 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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