NCT02684942

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Oct 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

January 29, 2016

Results QC Date

October 12, 2016

Last Update Submit

May 29, 2017

Conditions

PainQuality of Life

Keywords

MeperidineFentanylPain managementbrachytherapy

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    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.

    From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks

Secondary Outcomes (1)

  • Quality of Life

    From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks

Other Outcomes (4)

  • Ovoids Size

    after complete applicator insertion.

  • Tumor Size

    Before insert applicator in each fraction of brachytherapy.

  • Meperidine Dose

    after complete treatment.

  • +1 more other outcomes

Study Arms (6)

Meperidine,Fentanyl,Meperidine,Fentanyl

ACTIVE COMPARATOR

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: MeperidineDrug: Fentanyl

Fentanyl,Meperidine,Fentanyl,Meperidine

ACTIVE COMPARATOR

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: MeperidineDrug: Fentanyl

Meperidine,Meperidine,Fentanyl,Fentanyl

ACTIVE COMPARATOR

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: MeperidineDrug: Fentanyl

Fentanyl,Fentanyl,Meperidine,Meperidine

ACTIVE COMPARATOR

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: MeperidineDrug: Fentanyl

Meperidine,Fentanyl,Fentanyl,Meperidine

ACTIVE COMPARATOR

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: MeperidineDrug: Fentanyl

Fentanyl,Meperidine,Meperidine,Fentanyl

ACTIVE COMPARATOR

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: MeperidineDrug: Fentanyl

Interventions

MeperidineDRUG

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.

Also known as: Pethidine
Fentanyl,Fentanyl,Meperidine,MeperidineFentanyl,Meperidine,Fentanyl,MeperidineFentanyl,Meperidine,Meperidine,FentanylMeperidine,Fentanyl,Fentanyl,MeperidineMeperidine,Fentanyl,Meperidine,FentanylMeperidine,Meperidine,Fentanyl,Fentanyl
FentanylDRUG

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.

Also known as: Fentanil
Fentanyl,Fentanyl,Meperidine,MeperidineFentanyl,Meperidine,Fentanyl,MeperidineFentanyl,Meperidine,Meperidine,FentanylMeperidine,Fentanyl,Fentanyl,MeperidineMeperidine,Fentanyl,Meperidine,FentanylMeperidine,Meperidine,Fentanyl,Fentanyl

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Previously underwent intracavitary brachytherapy
  • Illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Davidson SE, Symonds RP, Lamont D, Watson ER. Does adenocarcinoma of uterine cervix have a worse prognosis than squamous carcinoma when treated by radiotherapy? Gynecol Oncol. 1989 Apr;33(1):23-6. doi: 10.1016/0090-8258(89)90596-9.

    PMID: 2495240BACKGROUND

  • Arunachalam D, Thirumoorthy A, Devi S, Thennarasu. Quality of Life in Cancer Patients with Disfigurement due to Cancer and its Treatments. Indian J Palliat Care. 2011 Sep;17(3):184-90. doi: 10.4103/0973-1075.92334.

    PMID: 22346042BACKGROUND

  • Dzeletovic I, Harrison ME, Crowell MD, Ramirez FC, Yows CR, Harris LA, Pasha SF, Gurudu SR, Leighton JA, Heigh RI. Impact of fentanyl in lieu of meperidine on endoscopy unit efficiency: a prospective comparative study in patients undergoing EGD. Gastrointest Endosc. 2013 Jun;77(6):883-7. doi: 10.1016/j.gie.2013.01.013. Epub 2013 Mar 6.

    PMID: 23472999BACKGROUND

  • Patel NC, Heckman MG, Palmer WC, Cangemi D, DeVault KR. A comparison of patient satisfaction with sedation between fentanyl/midazolam and meperidine/midazolam in patients undergoing endoscopy. Am J Gastroenterol. 2014 May;109(5):772-4. doi: 10.1038/ajg.2014.31. No abstract available.

    PMID: 24797008BACKGROUND

  • Kwekkeboom KL, Dendaas NR, Straub M, Bradley KA. Patterns of pain and distress during high-dose-rate intracavity brachytherapy for cervical cancer. J Support Oncol. 2009 May-Jun;7(3):108-14.

    PMID: 19507459BACKGROUND

  • Movafegh A, Ghafouri A, Nasr-Esfahani M, Gholamrezanezhad A, Madhkhan S. Post-thoracotomy analgesia--comparison epidural fentanyl to intravenous pethidine. Middle East J Anaesthesiol. 2007 Feb;19(1):111-22.

    PMID: 17511187BACKGROUND

  • Robertson DJ, Jacobs DP, Mackenzie TA, Oringer JA, Rothstein RI. Clinical trial: a randomized, study comparing meperidine (pethidine) and fentanyl in adult gastrointestinal endoscopy. Aliment Pharmacol Ther. 2009 Apr 15;29(8):817-23. doi: 10.1111/j.1365-2036.2009.03943.x. Epub 2009 Jan 20.

    PMID: 19154568BACKGROUND

  • Smith MD, Todd JG, Symonds RP. Analgesia for pelvic brachytherapy. Br J Anaesth. 2002 Feb;88(2):270-6. doi: 10.1093/bja/88.2.270.

    PMID: 11878659BACKGROUND

  • Soysal S, Karcioglu O, Demircan A, Topacoglu H, Serinken M, Ozucelik N, Tirpan K, Gunerli A. Comparison of meperidine plus midazolam and fentanyl plus midazolam in procedural sedation: a double-blind, randomized controlled trial. Adv Ther. 2004 Sep-Oct;21(5):312-21. doi: 10.1007/BF02850035.

    PMID: 15727400BACKGROUND

  • Agostoni M, Fanti L, Arcidiacono PG, Gemma M, Strini G, Torri G, Testoni PA. Midazolam and pethidine versus propofol and fentanyl patient controlled sedation/analgesia for upper gastrointestinal tract ultrasound endoscopy: a prospective randomized controlled trial. Dig Liver Dis. 2007 Nov;39(11):1024-9. doi: 10.1016/j.dld.2007.08.004. Epub 2007 Oct 29.

    PMID: 17913605RESULT

  • Thanthong S, Rojthamarat S, Worasawate W, Vichitvejpaisal P, Nantajit D, Ieumwananontachai N. Comparison of efficacy of meperidine and fentanyl in terms of pain management and quality of life in patients with cervical cancer receiving intracavitary brachytherapy: a double-blind, randomized controlled trial. Support Care Cancer. 2017 Aug;25(8):2531-2537. doi: 10.1007/s00520-017-3662-3. Epub 2017 Mar 18.

    PMID: 28315010DERIVED

MeSH Terms

Conditions

PainAgnosia

Interventions

MeperidineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Isonipecotic AcidsAcids, HeterocyclicHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Saengrawee Thanthong
Organization
Chulabhorn hospital
saengrawee81@gmail.com
+662-576-6021

Study Officials

  • Saengrawee Thanthong, RN.

    54 moo 4 Kampangpet 6 Taladbangken Laksi Bangkok, THAILAND 10210

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs, OCN

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 18, 2016

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

June 1, 2017

Results First Posted

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share