Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy
Condition: Pain; Quality of Life
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Meperidine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Pethidine; Fentanil
Intervention MeSH terms: Fentanyl; Meperidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meperidine; Fentanyl; Pain management; brachytherapy