Clinical trial NCT02684942: Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Quality of Life
Keywords: Meperidine
Fentanyl
Pain management
brachytherapy
Lead sponsor: Chulabhorn Cancer Center
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain Score
timeFrame: From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks
Other outcomes:
measure: Ovoids Size
timeFrame: after complete applicator insertion.
measure: Tumor Size
timeFrame: Before insert applicator in each fraction of brachytherapy.
measure: Meperidine Dose
timeFrame: after complete treatment.
measure: Fentanyl Dose
timeFrame: after complete treatment.
Locations:
Study officials:
affiliation: 54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210
name: Saengrawee Thanthong, RN.
role: PRINCIPAL_INVESTIGATOR
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