Phase 2
N=88
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT05487196 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Pain Burden, AUC (30 Minutes) — 101; 67; 39 pain units*minutes — p=0.226
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clonidine (Drug); Dexmedetomidine (Drug); Fentanyl (Drug); Ropivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Grace Lim, MD, MS
- Primary completion
- Jul 2023
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 Pain Scores |
1.7; 0.8; 0.5 | 0.22 |
| 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 |
Summary
The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.
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.