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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

Tracking Information
First Submitted Date  ICMJE January 29, 2016
First Posted Date  ICMJE February 18, 2016
Results First Submitted Date  ICMJE October 12, 2016
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
Pain Score [ Time Frame: From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Pain Score [ Time Frame: From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks ]
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.
Change History Complete list of historical versions of study NCT02684942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
Quality of Life [ Time Frame: From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Quality of Life [ Time Frame: From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks ]
Perceived Quality of life (EQ-5D) was assessed before the first brachytherpy and immediately after completion of each of the 4 brachytherapy fractions.
Current Other Pre-specified Outcome Measures
 (submitted: May 29, 2017)
  • Ovoids Size [ Time Frame: after complete applicator insertion. ]
    Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.
  • Tumor Size [ Time Frame: Before insert applicator in each fraction of brachytherapy. ]
    Size of tumor at cervix measured by the doctor before insert applicator.
  • Meperidine Dose [ Time Frame: after complete treatment. ]
    Sum of meperidine dose when finish each fraction of brachytherapy
  • Fentanyl Dose [ Time Frame: after complete treatment. ]
    Sum of fentanyl dose when finish each fraction of brachytherapy
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy
Official Title  ICMJE Comparison of Meperidine and Fentanyl on Pain Scale and Quality of Life in Cervical Cancer Patients Receiving Brachytherapy: A Double-blind, Randomized Controlled Trial
Brief Summary

Purpose: To compare the pain level and quality of life of the two sedation regimens consisting of diazepam in combination with meperidine or fentanyl.

Materials and methods: A total of 40 patients (160 sessions of brachytherapy), unselected brachytherapy out patients at Chulabhorn Hospital, Thailand were enrolled with informed consent and randomized to receive meperidine or fentanyl. Data of perceived pain (according to standard 10-cm visual analog scales [VAS]), and perceived Quality of life (EQ-5D) were collected. Patients and all brachytherapy staffs directly involved with the procedure were blinded about the drug used.

Detailed Description

Methods Patients Unselected, forty female adults, aged 20 years old or older, diagnosed with cervical cancer and treated with brachytherapy as outpatients at Chulabhorn Hospital, Thailand between June 2011 and September 2012 were enrolled in the study with their informed consents. The study was approved by The Chulabhorn Research Institutional Review Board and Chulabhorn Ethics committee. All the patients were treated with four sessions of ICRT(Intracavitary Radiation Therapy). Inclusion criteria were: Age 20 - 80 years, can understand and provide information, no trouble hearing and good conscious, agree to participated and had performance levels at ECOG 0-2. The patients were randomized to receive either meperidine (1 mg/kg) or fentanyl (1 ug/kg) with diazepam 10 mg both. Nursing staffs who prepared the drugs picked the drugs from lotteries organized into 6 lots on it.

Procedures Perceived pain score according to standard 10-cm visual analog scales (VAS) was assessed prior to treatment and every 15 minutes from the start to the end of the ICRT procedure. Perceived Quality of life (EQ-5D) was assessed before the treatment and immediately after the completion of each brachytherapy treatment session. Information regarding which drug was used was concealed to all the patients and brachytherapy staffs directly involved with the procedures. The procedures involved a radiation oncologist, two nurses, a practical nurse, a radiotherapist, and a medical physicist.

Firstly, before the procedure the patients must NPO(Nothing per oral) for 6 hours and was inserted with intravenous catheter for IV sedation drug depending on the randomized drug that they received.

Secondly, the patients laid down on brachytherapy stretcher and were treated according to the standard ICRT protocol. Each randomized patient had 4 fractions of ICRT, so a single patient will receive Fentanyl and Diazepam 2 fractions and Meperidine and Diazepam 2 fractions. The drugs used were diluted with normal saline to 10 ml. and labeled as "Protocol drug". The actual content within the syringes was known only to a nurse that did not directly involve in the study. Syringes prepared for the meperidine group contained 50 mg of meperidine, while syringes prepared for the fentanyl group contained 100 mg of fentanyl. Both drugs were drawn into 10-cc syringes and appeared colorless.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Quality of Life
Intervention  ICMJE
  • Drug: Meperidine
    Injection meperidine 1 mg/kg with diazepam 0.1 mg/kg.to intravenous 5 minutes before inserting the applicator and then when the patients had pain score greater or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.
    Other Name: Pethidine
  • Drug: Fentanyl
    Injection 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. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.
    Other Name: Fentanil
Study Arms  ICMJE
  • Active Comparator: Meperidine,Fentanyl,Meperidine,Fentanyl
    Injection 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 at first and third fraction of brachytherapy. And injection 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 at second and fourth fraction of brachytherapy.
    Interventions:
    • Drug: Meperidine
    • Drug: Fentanyl
  • Active Comparator: Fentanyl,Meperidine,Fentanyl,Meperidine
    Injection 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 at second and fourth fraction of brachytherapy. And injection fentanyl 1 umg/kg to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4 at first and third fraction of brachytherapy.
    Interventions:
    • Drug: Meperidine
    • Drug: Fentanyl
  • Active Comparator: Meperidine,Meperidine,Fentanyl,Fentanyl
    Injection 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 at first and second fraction of brachytherapy. And injection 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 at third and fourth fraction of brachytherapy.
    Interventions:
    • Drug: Meperidine
    • Drug: Fentanyl
  • Active Comparator: Fentanyl,Fentanyl,Meperidine,Meperidine
    Injection 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 at third and fourth fraction of brachytherapy. And injection 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 at first and second fraction.
    Interventions:
    • Drug: Meperidine
    • Drug: Fentanyl
  • Active Comparator: Meperidine,Fentanyl,Fentanyl,Meperidine
    Injection 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 at first and fourth fraction of brachytherapy. And injection fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score more than 4 at second and third fraction of brachytherapy.
    Interventions:
    • Drug: Meperidine
    • Drug: Fentanyl
  • Active Comparator: Fentanyl,Meperidine,Meperidine,Fentanyl
    Injection 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 at second and third fractionof brachytherapy. And injection 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 at first and fourth fraction of brachytherapy.
    Interventions:
    • Drug: Meperidine
    • Drug: Fentanyl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 20 years old or older,
  • Diagnosed with cervical cancer
  • On course of external Radiation therapy
  • Treated with brachytherapy 4 times.

Exclusion Criteria:

  • Pregnant
  • Previously underwent intracavitary brachytherapy
  • Illiterate
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02684942
Other Study ID Numbers  ICMJE 20/2553
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Saengrawee Thanthong, Chulabhorn Cancer Center
Study Sponsor  ICMJE Chulabhorn Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saengrawee Thanthong, RN. 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210
PRS Account Chulabhorn Cancer Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP