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A clinical trial to compare the effectiveness of acetaminophen and pethidine injection in labor pain reduction in pregnant women

Protocol summary

Summary
Objective: To compare the effectiveness of acetaminophen and pethidine injection in reducing labor pain in pregnant women. Design: A randomized, double-blind, clinical trial based on random number table. Study population: Laboring women requesting pain relief. Inclusion criteria: Term pregnancy, request for pain relief; singleton pregnancy with cephalic presentation; no growth impairment or fetal abnormalities. Exclusion criteria: Medical history of diseases (hepatic, renal, cardiovascular, or respiratory diseases, preeclampsia, diabetes, addiction, allergy to acetaminophen and drug abuse, and G6PD deficiency); need for induction; fetal distress; history of cesarean section. Sample size: 100 cases. Study intervention: The control group will receive 1000 mg of acetaminophen injection in 100 cc of lactate ringer serum during 15 min, and at the same time, injection 5 cc of distilled water in angiocath during 2 min. The intervention group will receive 5 mg injection of pethidine diluted in 5 cc distilled water during 2 min, and simultaneously, 100 cc lactated Ringer’s solution will be injected with Micro Drape during 15 minutes. Study outcome: Evaluation and comparison of pain level based on VAS score before and 15 min, 30 min, 1 h, 2 h, 3 h, and 4 h between the intervention and control groups after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100736610N1
Registration date: 2017-10-20, 1396/07/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-20, 1396/07/28
Registrant information
Name
Mozhgan Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 5886
Email address
soltanim934@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of acetaminophen and pethidine injection in labor pain reduction in pregnant women
Public title
Comparison of acetaminophen and pethidine in labor pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Term pregnancy, request for pain relief; singleton pregnancy with cephalic presentation; no growth impairment or fetal abnormalities. Exclusion criteria: Medical history of diseases (hepatic, renal, cardiovascular, or respiratory diseases, preeclampsia, diabetes, addiction, allergy to acetaminophen and drug abuse, and G6PD deficiency); need for induction; fetal distress; history of cesarean section.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
IR.MUMS.sm.REC.1396.95

Health conditions studied

1

Description of health condition studied
pregnant women
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy

Primary outcomes

1

Description
Pain level
Timepoint
Before and 15 min, 30 min, 1 h, 2 h, 3 h, and 4 h after intervention
Method of measurement
VAS score

Secondary outcomes

empty

Intervention groups

1

Description
Control group: who is receiving 1000 mg of acetaminophen injection in 100 cc of lactate ringer serum during 15 min, and at the same time, injection 5 cc of distilled water in angiocath during 2 min.
Category
Treatment - Drugs

2

Description
Intervention group: who is receiving 5 mg injection of pethidine diluted in 5 cc distilled water during 2 min, and simultaneously, 100 cc lactated Ringer’s solution will be injected with Micro Drape during 15 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mozhgan Soltani
Street address
Ghaem Hospital, Ahmad Abad Street, Dr. Shariati Square
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mozhgan Soltani
Position
Gynaecologist
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Street, Dr. Shariati Square
City
Mashhad
Postal code
Phone
+98 51 3843 0569
Fax
Email
SoltaniM933@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mozhgan Soltani
Position
Gynaecologist
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Street, Dr. Shariati Square
City
Mashhad
Postal code
Phone
+98 51 3843 0569
Fax
Email
SoltaniM933@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mozhgan Soltani
Position
Gynaecologist
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Street, Dr. Shariati Square
City
Mashhad
Postal code
Phone
+98 51 3843 0569
Fax
Email
SoltaniM933@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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