Phase 2
Completed N=88
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
Pregnancy Related
Source: ClinicalTrials.gov NCT05487196 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Pain Burden, AUC (30 Minutes) — 101; 67; 39 pain units*minutes — p=0.226
Summary
The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Burden, AUC (30 Minutes) |
101; 67; 39 | 0.226 |
| SECONDARY Pain Burden, AUC (120 Minutes) |
133; 67; 45 | 0.16 |
| SECONDARY Pain Scores |
1.7; 0.8; 0.5 | 0.22 |
| SECONDARY Cesarean Delivery |
3; 1; 3 | 0.28 |
| SECONDARY Hypotension |
13; 10; 11 | 0.83 |
| SECONDARY Nausea |
5; 4; 5 | 0.01 sig |
| SECONDARY Vomiting |
1; 0; 1 | 0.36 |
| SECONDARY Shivering |
6; 4; 7 | 0.36 |
| SECONDARY Pruritus |
3; 0; 5 | 0.54 |
| SECONDARY Patient Treatment Satisfaction |
10; 10; 10 | 0.58 |
| SECONDARY Newborn Apgar Score |
9; 8; 8.5 | 0.98 |
Eligibility Criteria
Pregnant minors were not enrolled in this trial.
Inclusion Criteria
- Pregnant women greater than 18 years of age
- American Society of Anesthesiologists (ASA) Physical Status 2 or 3
- Term pregnancy (greater than 37 gestational weeks)
- Planning epidural labor analgesia
- Singleton pregnancy
- Vertex presentation
- Planned vaginal delivery
Exclusion Criteria
- Pre-eclampsia with or without severe features
- New initiation of antihypertensive agent within 24 hours prior to enrollment
- Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac]
- Known or suspected fetal abnormalities
- Allergy to study agents
- Contra-indication to neuraxial anesthesia
- Inability to communicate or participate in study procedures
Data sourced from ClinicalTrials.gov (NCT05487196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.