Trial Outcomes & Findings for Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy (NCT NCT02684942)
NCT ID: NCT02684942
Last Updated: 2017-06-01
Results Overview
Perceived pain score according to standard 10-cm visual analog scales (VAS) was assessed before injection of medicine for every 15 minutes up to 120 minutes.The minimum and maximum scores were 0, 10. Score 0 means no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain and 10 worst pain.
COMPLETED
PHASE4
40 participants
From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks
2017-06-01
Participant Flow
The study design is cross-over in female outpatients with cervical cancer (age, 20-80 years) stage IB-IVB treated with four fractions of brachytherapy from June 2013 to September 2014 were enrolled in the study.
Forty patients with cervical cancer were enrolled in the study. The exclusion criteria were prior pelvic brachytherapy and a history of allergy to meperidine, fentanyl, or benzodiazepine and none were subsequently excluded.
Participant milestones
| Measure |
Meperidine,Fentanyl,Meperidine,Fentanyl
First and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
|
Fentanyl,Meperidine,Fentanyl,Meperidine
First and Third Intervention inject inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
|
Meperidine,Meperidine,Fentanyl,Fentanyl
First and Second Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Third and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
|
Fentanyl,Fentanyl,Meperidine,Meperidine
First and Second Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Third and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
|
Meperidine,Fentanyl,Fentanyl,Meperidine
First and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Third Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
|
Fentanyl,Meperidine,Meperidine,Fentanyl
First and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
Second and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy
Baseline characteristics by cohort
| Measure |
All Participants
n=40 Participants
All participants who enrolled to this study.
|
|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Radiation modality
2D, two-dimensional
|
30 participants
n=5 Participants
|
|
Radiation modality
3D conformal
|
10 participants
n=5 Participants
|
|
FIGO stage
IB
|
5 participants
n=5 Participants
|
|
FIGO stage
IIA1
|
2 participants
n=5 Participants
|
|
FIGO stage
IIA2
|
1 participants
n=5 Participants
|
|
FIGO stage
IIB
|
16 participants
n=5 Participants
|
|
FIGO stage
IIIB
|
15 participants
n=5 Participants
|
|
FIGO stage
IVB
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeksPerceived pain score according to standard 10-cm visual analog scales (VAS) was assessed before injection of medicine for every 15 minutes up to 120 minutes.The minimum and maximum scores were 0, 10. Score 0 means no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain and 10 worst pain.
Outcome measures
| Measure |
Meperidine
n=80 fraction
Separate analysis in meperidine group.
|
Fentanyl
n=80 fraction
Separate analysis in fentanyl group.
|
|---|---|---|
|
Pain Score
baseline
|
0.04 units on a scale
Standard Deviation 0.25
|
0.14 units on a scale
Standard Deviation 0.55
|
|
Pain Score
0 minute
|
0.49 units on a scale
Standard Deviation 1.18
|
0.40 units on a scale
Standard Deviation 1.16
|
|
Pain Score
15 minute
|
0.59 units on a scale
Standard Deviation 1.38
|
0.65 units on a scale
Standard Deviation 1.21
|
|
Pain Score
30 minute
|
1.05 units on a scale
Standard Deviation 1.76
|
1.24 units on a scale
Standard Deviation 2.21
|
|
Pain Score
45 minute
|
1.33 units on a scale
Standard Deviation 2.09
|
1.70 units on a scale
Standard Deviation 2.48
|
|
Pain Score
60 minute
|
0.61 units on a scale
Standard Deviation 1.48
|
0.81 units on a scale
Standard Deviation 1.83
|
|
Pain Score
75 minute
|
0.49 units on a scale
Standard Deviation 0.99
|
0.53 units on a scale
Standard Deviation 1.12
|
|
Pain Score
90 minute
|
0.24 units on a scale
Standard Deviation 0.80
|
0.13 units on a scale
Standard Deviation 0.58
|
|
Pain Score
105 minute
|
0.24 units on a scale
Standard Deviation 0.80
|
0.13 units on a scale
Standard Deviation 0.58
|
|
Pain Score
120 minute
|
0.24 units on a scale
Standard Deviation 0.80
|
0.13 units on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeksPopulation: Pain score in each fraction.
Perceived Quality of life (EQ-5D) was assessed before the first brachytherpy and immediately after completion of each of the 4 brachytherapy fractions. The EQ-5D have 5 dimensions: mobility, self-care, usual activities, topics each content 3 responses: no problems, some problems, extreme problems.
Outcome measures
| Measure |
Meperidine
n=80 fraction
Separate analysis in meperidine group.
|
Fentanyl
n=80 fraction
Separate analysis in fentanyl group.
|
|---|---|---|
|
Quality of Life
Some problems in mobility
|
16 participants
|
18 participants
|
|
Quality of Life
No problems in mobility
|
62 participants
|
58 participants
|
|
Quality of Life
Severe problems in mobility
|
1 participants
|
1 participants
|
|
Quality of Life
No problem in self-care
|
68 participants
|
69 participants
|
|
Quality of Life
Some problem in self-care
|
11 participants
|
6 participants
|
|
Quality of Life
Severe problem in self-care
|
0 participants
|
2 participants
|
|
Quality of Life
No problem in usual activities
|
55 participants
|
53 participants
|
|
Quality of Life
Some problem in usual activities
|
22 participants
|
21 participants
|
|
Quality of Life
Severe problem in usual activities
|
2 participants
|
3 participants
|
|
Quality of Life
No problem in pain/discomfort
|
27 participants
|
23 participants
|
|
Quality of Life
Some problem in pain/discomfort
|
49 participants
|
53 participants
|
|
Quality of Life
Severe problem in pain/discomfort
|
3 participants
|
1 participants
|
|
Quality of Life
No problem in anxiety/depression
|
46 participants
|
42 participants
|
|
Quality of Life
Some problem in anxiety/depression
|
32 participants
|
33 participants
|
|
Quality of Life
Severe problem in anxiety/depression
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after complete applicator insertion.Population: Each patient was treated with 4 fractions of brachytherapy.
Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.
Outcome measures
| Measure |
Meperidine
n=80 fraction
Separate analysis in meperidine group.
|
Fentanyl
n=80 fraction
Separate analysis in fentanyl group.
|
|---|---|---|
|
Ovoids Size
|
2 Centimeter
Interval 1.5 to 3.0
|
2 Centimeter
Interval 1.5 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before insert applicator in each fraction of brachytherapy.Population: Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.
Size of tumor at cervix measured by the doctor before insert applicator.
Outcome measures
| Measure |
Meperidine
n=80 fraction
Separate analysis in meperidine group.
|
Fentanyl
n=80 fraction
Separate analysis in fentanyl group.
|
|---|---|---|
|
Tumor Size
|
2.23 CM.
Standard Deviation 1.29
|
2.21 CM.
Standard Deviation 1.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after complete treatment.Population: Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.
Sum of meperidine dose when finish each fraction of brachytherapy
Outcome measures
| Measure |
Meperidine
n=80 fraction
Separate analysis in meperidine group.
|
Fentanyl
Separate analysis in fentanyl group.
|
|---|---|---|
|
Meperidine Dose
|
50.13 mg.
Standard Deviation 0.26
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after complete treatment.Population: Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.
Sum of fentanyl dose when finish each fraction of brachytherapy
Outcome measures
| Measure |
Meperidine
n=80 fraction
Separate analysis in meperidine group.
|
Fentanyl
Separate analysis in fentanyl group.
|
|---|---|---|
|
Fentanyl Dose
|
100.18 ug.
Standard Deviation 0.32
|
—
|
Adverse Events
Meperidine
Fentanyl
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place