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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

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.


Condition or disease Intervention/treatment Phase
Pain Quality of Life Drug: Meperidine Drug: Fentanyl Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Meperidine and Fentanyl on Pain Scale and Quality of Life in Cervical Cancer Patients Receiving Brachytherapy: A Double-blind, Randomized Controlled Trial
Study Start Date : October 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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

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.
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

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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Ovoids Size [ Time Frame: after complete applicator insertion. ]
    Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.

  2. Tumor Size [ Time Frame: Before insert applicator in each fraction of brachytherapy. ]
    Size of tumor at cervix measured by the doctor before insert applicator.

  3. Meperidine Dose [ Time Frame: after complete treatment. ]
    Sum of meperidine dose when finish each fraction of brachytherapy

  4. Fentanyl Dose [ Time Frame: after complete treatment. ]
    Sum of fentanyl dose when finish each fraction of brachytherapy



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684942


Sponsors and Collaborators
Chulabhorn Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Saengrawee Thanthong, RN. 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Saengrawee Thanthong, Mrs, OCN, Chulabhorn Cancer Center
ClinicalTrials.gov Identifier: NCT02684942     History of Changes
Other Study ID Numbers: 20/2553
First Posted: February 18, 2016    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Saengrawee Thanthong, Chulabhorn Cancer Center:
Meperidine
Fentanyl
Pain management
brachytherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Fentanyl
Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics