Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

NCT04331210 | Unknown

• 1 other identifier: Post episiotomy analgesia
• Study Type: interventional
• Target: 1,024
• Locations: 0 countries
• Sites: N/A

Brief Summary

Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.

Conditions

Episiotomy Wound

Keywords

Episiotomy

Outcome Measures

Primary Outcomes (1)

• Post episiotomy pain relief

  The relief of pain after delivery measured by pain relief scale..Pain relief scale Title: pain intensity scale Minimum 0 means no pain Maximum 4 means severe pain

  First three days after delivery

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Using diclofenac sodium suppository 50 mg immediately after suturing and then every 8 hours

Drug: Diclofenac Sodium

Group 2

ACTIVE COMPARATOR

Using diclofenac sodium tablets 50 mg every 8 hours after birth

Drug: Diclofenac Sodium

Interventions

Diclofenac Sodium DRUG

Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic

Group 1; Group 2

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 20:35 years.
• Primigravidae as elective procedure.
• face to pubis delivery.
• Big baby.
• Narrow pelvic arch.
• Elderly primigravida.
• old perineal scar as episiotomy or perineorrhaphy.
• Manipulative delivery.
• To cut short second stage cases such as pre eclampsia.
• Premature baby.
• Fetal distress.

You may not qualify if:

• more than 35 years.
• pelvic inflammatory disease.

Sponsors & Collaborators

• Assiut University: lead

Related Links

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MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Diaa eldin Mohammed, Professor

  women health hospital assiut university

  STUDY CHAIR

• Osama Saber, Lecturer

  women health hospital assiut university

  STUDY DIRECTOR

Central Study Contacts

Mohammed Hosny, Physician

CONTACT

01140762577; Elto3my@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 2, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Will be available for sharing within 6 month of completion of the study
• Access Criteria: Data access requests will be reviewed by an external independent review panel.requestorswill be required to sign a data access agreement