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Trial record 32 of 326 for:    clonidine

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain

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ClinicalTrials.gov Identifier: NCT01846221
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Allison Lee, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Labor Pain
Interventions Drug: Clonidine
Drug: Fentanyl
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Period Title: Overall Study
Started 50 51
Completed 47 51
Not Completed 3 0
Reason Not Completed
Catheter Failure             2             0
Age Exclusion             1             0
Arm/Group Title Clonidine Fentanyl Total
Hide Arm/Group Description

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Total of all reporting groups
Overall Number of Baseline Participants 47 51 98
Hide Baseline Analysis Population Description
3 subjects in the Clonidine group were not included in the analysis due to the following reasons: 2 catheter failures, 1 age limit exclusion.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 51 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
 100.0%
51
 100.0%
98
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 51 participants 98 participants
Female
47
 100.0%
51
 100.0%
98
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 51 participants 98 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   6.4%
3
   5.9%
6
   6.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  34.0%
10
  19.6%
26
  26.5%
White
27
  57.4%
31
  60.8%
58
  59.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.1%
7
  13.7%
8
   8.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 51 participants 98 participants
47 51 98
1.Primary Outcome
Title Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection
Hide Description Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. ‘Success’ is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)
Time Frame Baseline, 15 Minutes post epidural administration
Hide Outcome Measure Data
Hide Analysis Population Description
3 subjects in the Clonidine group were not included in the analysis due to the following reasons: 2 catheter failures, 1 age exclusion.
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description:

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Overall Number of Participants Analyzed 47 51
Measure Type: Count of Participants
Unit of Measure: Participants
31
  66.0%
38
  74.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine, Fentanyl
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Maternal Systolic Blood Pressure
Hide Description Blood pressure will be measured at different timepoints.
Time Frame Baseline, 30 Minutes post epidural administration
Hide Outcome Measure Data
Hide Analysis Population Description
46 out of 47 participants were included from the Clonidine group due to 1 participant did not have blood pressure taken at 30 minutes. 48 out of 51 participants were included from the Fentanyl group due to 3 participants did not have blood pressure taken at 30 minutes.
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description:

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Overall Number of Participants Analyzed 46 48
Mean (Full Range)
Unit of Measure: mm Hg
Baseline
123
(91 to 172)
121
(83 to 146)
30 Minutes
116
(87 to 150)
118
(87 to 141)
3.Secondary Outcome
Title Maternal Heart Rate
Hide Description Heart rate will be measured at different timepoints.
Time Frame Baseline, 30 Minutes post epidural administration
Hide Outcome Measure Data
Hide Analysis Population Description
48 out of 51 participants were included from the Fentanyl group due to 4 participants did not have heart rate taken at 30 minutes.
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description:

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Overall Number of Participants Analyzed 47 48
Mean (Full Range)
Unit of Measure: beats per minute (BPM)
Baseline
87
(57 to 155)
84
(65 to 113)
30 Minutes
84
(54 to 131)
85
(62 to 112)
4.Secondary Outcome
Title Neonatal Apgar Score
Hide Description The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Time Frame 1 minute and 5 minutes post delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description:

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Overall Number of Participants Analyzed 47 51
Mean (Full Range)
Unit of Measure: Apgar score
1 Minute
8.53
(6 to 9)
8.24
(1 to 9)
5 Minutes
8.94
(8 to 9)
8.88
(6 to 9)
5.Secondary Outcome
Title Number of Spontaneous Vaginal Deliveries
Hide Description Mode of delivery: spontaneous vaginal or instrumental vaginal versus cesarean.
Time Frame Upon delivery (approximately up to 8 hours from baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description:

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

Overall Number of Participants Analyzed 47 51
Measure Type: Number
Unit of Measure: spontaneous vaginal deliveries
38 40
Time Frame Up to 2 hours after initial epidural bolus (study drug) injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clonidine Fentanyl
Hide Arm/Group Description

Participants randomized to this arm of the study receive 100 micrograms clonidine with the bupivacaine in their epidural when requesting pain relief in advanced labor

Clonidine: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.

Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.

All-Cause Mortality
Clonidine Fentanyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/51 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine Fentanyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clonidine Fentanyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/51 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Allison Lee, MD - Assistant Professor of Anesthesiology
Organization: Columbia University
Phone: 212-342-2028
EMail: al3196@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Allison Lee, Columbia University
ClinicalTrials.gov Identifier: NCT01846221     History of Changes
Other Study ID Numbers: AAAL4101
First Submitted: May 1, 2013
First Posted: May 3, 2013
Results First Submitted: March 8, 2018
Results First Posted: May 3, 2018
Last Update Posted: May 3, 2018