Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Pain

Quality of Life

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anticonvulsants

Antiemetics

Muscle Relaxants, Central

Psychotropic Drugs

Gastrointestinal Agents

Fentanyl

Diazepam

Meperidine

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

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.

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.

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.

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.

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.

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.

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.

Saengrawee Thanthong, RN.

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.

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.

Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy

Comparison of Meperidine and Fentanyl on Pain Scale and Quality of Life in Cervical Cancer Patients Receiving Brachytherapy: A Double-blind, Randomized Controlled Trial

Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.

Size of tumor at cervix measured by the doctor before insert applicator.

Sum of meperidine dose when finish each fraction of brachytherapy

Sum of fentanyl dose when finish each fraction of brachytherapy

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.

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.

Chulabhorn Cancer Center

Mrs, OCN

Adverse events were monitored throughout each 1-day intervention

All participants who enrolled to this study.

All Participants

Age, Continuous

Sex: Female, Male

2D, two-dimensional

3D conformal

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.

Radiation modality

IIA1

IIA2

IIIB

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.

FIGO stage

Saengrawee Thanthong

baseline

0 minute

15 minute

30 minute

45 minute

60 minute

75 minute

90 minute

105 minute

120 minute

Pain Score

No problems in mobility

Some problems in mobility

Severe problems in mobility

No problem in self-care

Some problem in self-care

Severe problem in self-care

No problem in usual activities

Some problem in usual activities

Severe problem in usual activities

No problem in pain/discomfort

Some problem in pain/discomfort

Severe problem in pain/discomfort

No problem in anxiety/depression

Some problem in anxiety/depression

Severe problem in anxiety/depression

Separate analyze in fraction that patient receive meperidine.

Separate analyze in fraction that patient received fentanyl.

Each patient was treated with 4 fractions of brachytherapy.

Ovoids Size

Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.

Tumor Size

Meperidine Dose

Fentanyl Dose

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.

Meperidine,Fentanyl,Meperidine,Fentanyl

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.

Fentanyl,Meperidine,Fentanyl,Meperidine

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.

Meperidine,Meperidine,Fentanyl,Fentanyl

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.

Fentanyl,Fentanyl,Meperidine,Meperidine

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.

Meperidine,Fentanyl,Fentanyl,Meperidine

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.

Fentanyl,Meperidine,Meperidine,Fentanyl

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Cholangiocarcinoma

Pancreatic Neoplasms

Pancreatitis

Choledocholithiasis

Gastrointestinal Diseases

Pancreatic Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Diseases

Common Bile Duct Diseases

Biliary Tract Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Pancreatic Cancer

Bile Duct Cancer

Midazolam

Etomidate

Hypnotics and Sedatives

Anti-Anxiety Agents

GABA Modulators

Neurotransmitter Agents

This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.

This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.

Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.

BYUNG HYO CHA, Dr.

Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.

ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.

Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.

In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.

Etomidate vs. Midazolam for Sedation During ERCP

Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)

The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.

Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter \< 90%

Cheju Halla General Hospital

Director of Endoscopy clinic, Digestive Disease Center, Department of Internal Medicine

Additional probable side events, such as, paradoxic reaction in MDZ group, and myoclonus in ETM group were counted during the whole 3 phases of procedure.

This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.

Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.

Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.

This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.

Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.

Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.

Total

Body Mass Index (kg/square of m.)

Procedure Time (min)

1. To standardize proper sedation level we used Ramsay Sedation Scale but this scale could be calculated subjectively.
2. Double blindness was not applied strictly because of quite different pharmacodynamics of two experimental drugs.

Dr. Byung Hyo Cha, Director of ETOMI-1 study

If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.

Number of Intervention

All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p \< 0.05 was considered statistically significant.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy	NCT02684942	Pain Quality of Life	Meperidine Fentanyl	20 Years - 80 Years	Chulabhorn Cancer Center
Comparison of Meperidine and Fentanyl on Pain Scale and QOL in Brachytherapy	NCT02684942	Pain Quality of Life	Meperidine Fentanyl	20 Years - 80 Years	Chulabhorn Cancer Center
Etomidate vs. Midazolam for Sedation During ERCP	NCT02027311	Choledocholithi... Cholangiocarcin... Pancreatitis Pancreatic Canc...	Etomidate Midazolam Meperidine	20 Years - 90 Years	Cheju Halla General Hospital

Spots Global Cancer Trial Database for meperidine

Every month we try and update this database with for meperidine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for meperidine

Every month we try and update this database with for meperidine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for meperidine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.