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Trial record 1 of 3 for:    "Cervix Carcinoma" | "Adjuvants, Anesthesia"
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Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy

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ClinicalTrials.gov Identifier: NCT02684942
Recruitment Status : Completed
First Posted : February 18, 2016
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Saengrawee Thanthong, Chulabhorn Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pain
Quality of Life
Interventions Drug: Meperidine
Drug: Fentanyl
Enrollment 40
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Meperidine,Fentanyl,Meperidine,Fentanyl Fentanyl,Meperidine,Fentanyl,Meperidine Meperidine,Meperidine,Fentanyl,Fentanyl Fentanyl,Fentanyl,Meperidine,Meperidine Meperidine,Fentanyl,Fentanyl,Meperidine Fentanyl,Meperidine,Meperidine,Fentanyl
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 7 7 7 7 6 6
Completed 7 7 7 7 6 6
Not Completed 0 0 0 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All participants who enrolled to this study.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
56.7  (12.9)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
40
 100.0%
Male
0
   0.0%
[1]
Measure Description: Study in patients with cervical cancer.
Radiation modality   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
2D, two-dimensional 30
3D conformal 10
[1]
Measure Description: Generally, the brachytherapy technique divided into two methods; 1.2D method is based on 2D imaging x-ray 2.3D method is based on 3D imaging which have been incorporated into treatment planning methods, allowing full 3D dose distributions to be computed.
FIGO stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
IB 5
IIA1 2
IIA2 1
IIB 16
IIIB 15
IVB 1
[1]
Measure Description:

Cervical cancer staging at diagnosis was based on the International Federation of Gynecology and Obstetrics (FIGO).

Stage I is the least severe, where the tumor is confined to the cervix. Stage II Tumor invades beyond uterus but not to pelvic wall or lower third of vagina.

Stage III Extends to pelvic wall and/or lower 1/3 vagina and/or causes hydronephrosis or nonfunctional kidney.

Stage IV Is the most severe, Tumor invades mucosa of bladder or rectum and/or extends beyond true pelvis.

1.Primary Outcome
Title Pain Score
Hide Description 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.
Time Frame From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Meperidine Fentanyl
Hide Arm/Group Description:
Separate analysis in meperidine group.
Separate analysis in fentanyl group.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Fraction
80 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 0.04  (0.25) 0.14  (0.55)
0 minute 0.49  (1.18) 0.40  (1.16)
15 minute 0.59  (1.38) 0.65  (1.21)
30 minute 1.05  (1.76) 1.24  (2.21)
45 minute 1.33  (2.09) 1.70  (2.48)
60 minute 0.61  (1.48) 0.81  (1.83)
75 minute 0.49  (0.99) 0.53  (1.12)
90 minute 0.24  (0.80) 0.13  (0.58)
105 minute 0.24  (0.80) 0.13  (0.58)
120 minute 0.24  (0.80) 0.13  (0.58)
2.Secondary Outcome
Title Quality of Life
Hide Description 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.
Time Frame From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pain score in each fraction.
Arm/Group Title Meperidine Fentanyl
Hide Arm/Group Description:
Separate analyze in fraction that patient receive meperidine.
Separate analyze in fraction that patient received fentanyl.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Fraction
80 80
Measure Type: Number
Unit of Measure: participants
No problems in mobility 62 58
Some problems in mobility 16 18
Severe problems in mobility 1 1
No problem in self-care 68 69
Some problem in self-care 11 6
Severe problem in self-care 0 2
No problem in usual activities 55 53
Some problem in usual activities 22 21
Severe problem in usual activities 2 3
No problem in pain/discomfort 27 23
Some problem in pain/discomfort 49 53
Severe problem in pain/discomfort 3 1
No problem in anxiety/depression 46 42
Some problem in anxiety/depression 32 33
Severe problem in anxiety/depression 1 2
3.Other Pre-specified Outcome
Title Ovoids Size
Hide Description Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.
Time Frame after complete applicator insertion.
Hide Outcome Measure Data
Hide Analysis Population Description
Each patient was treated with 4 fractions of brachytherapy.
Arm/Group Title Meperidine Fentanyl
Hide Arm/Group Description:
Analyze in meperidine group.
Analyze in fentanyl group.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Fraction
80 80
Median (Full Range)
Unit of Measure: Centimeter
2
(1.5 to 3)
2
(1.5 to 3)
4.Other Pre-specified Outcome
Title Tumor Size
Hide Description Size of tumor at cervix measured by the doctor before insert applicator.
Time Frame Before insert applicator in each fraction of brachytherapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.
Arm/Group Title Meperidine Fentanyl
Hide Arm/Group Description:
Separate analyze in fraction that patient receive meperidine.
Separate analyze in fraction that patient received fentanyl.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Fraction
80 80
Mean (Standard Deviation)
Unit of Measure: CM.
2.23  (1.29) 2.21  (1.25)
5.Other Pre-specified Outcome
Title Meperidine Dose
Hide Description Sum of meperidine dose when finish each fraction of brachytherapy
Time Frame after complete treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.
Arm/Group Title Meperidine
Hide Arm/Group Description:
Analyze in meperidine group.
Overall Number of Participants Analyzed 40
Overall Number of Units Analyzed
Type of Units Analyzed: Fraction
80
Mean (Standard Deviation)
Unit of Measure: mg.
50.13  (0.26)
6.Other Pre-specified Outcome
Title Fentanyl Dose
Hide Description Sum of fentanyl dose when finish each fraction of brachytherapy
Time Frame after complete treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.
Arm/Group Title Fentanyl
Hide Arm/Group Description:
Analyze in fentanyl group.
Overall Number of Participants Analyzed 40
Overall Number of Units Analyzed
Type of Units Analyzed: Fraction
80
Mean (Standard Deviation)
Unit of Measure: ug.
100.18  (0.32)
Time Frame 1-day
Adverse Event Reporting Description Adverse events were monitored throughout each 1-day intervention
 
Arm/Group Title Meperidine Fentanyl
Hide Arm/Group Description Analyze in meperidine group. Analyze in fentanyl group.
All-Cause Mortality
Meperidine Fentanyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Meperidine Fentanyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Meperidine Fentanyl
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Saengrawee Thanthong
Organization: Chulabhorn hospital
Phone: +662-576-6021
Other Publications:
Responsible Party: Saengrawee Thanthong, Chulabhorn Cancer Center
ClinicalTrials.gov Identifier: NCT02684942     History of Changes
Other Study ID Numbers: 20/2553
First Submitted: January 29, 2016
First Posted: February 18, 2016
Results First Submitted: October 12, 2016
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017