Efficacy of Single Dose Rectal Diclofenac With Oral Diclofenac for the Relief of Perineal Pain Within 24 Hours After Episiotomy
Overall Comparison of Single Dose 100mg Rectal Diclofenac With Double Doses of 20mg Twelve Hours Apart Oral Diclofenac for Pain Relief Both for 24 Hours After Episiorrhahpy, Southeast Nigeria.
1 other identifier
interventional
146
1 country
2
Brief Summary
Episiotomy is the commonest surgical procedure performed on parturient. It is usually associated with perineal pain which is particularly severe in the first 24 hours post repair. Perineal pain after episiorrhaphy if not adequately managed puts the woman into painful distress thus preventing good immediate post-partum care for the newborn. The aim is to compare the efficacy of single dose rectal diclofenac with oral diclofenac for the relief of perineal pain within 24 hours after episiotomy repair at Alex Ekwueme Federal University Teaching Hospital Abakaliki.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
January 14, 2024
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedJanuary 23, 2024
January 1, 2024
7 months
January 14, 2024
January 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adequate pain relief after drug administration
Clients satisfaction
24hours
Study Arms (2)
Arm 1, oral diclofenac
ACTIVE COMPARATORTwo doses of 50mg oral diclofenac 12 hours apart was administered to this arm
Arm 2, rectal diclofenac
ACTIVE COMPARATOR100mg diclofenac was administered rectally to this arm
Interventions
Each were monitored for pain within 24 hours
Eligibility Criteria
You may qualify if:
- Uncomplicated pregnancy
- Gestational age of 37 weeks and above who had episiotomy
- Singleton gestation
- Vaginal delivery
- Instrumental vaginal delivery
- Consented women
You may not qualify if:
- Women that declined consent
- Postpartum hemorrhage.
- Women who had perineal tear
- History of peptic ulcer diseases
- History of bleeding coagulopathies
- Adverse reaction or hypersensitivity to diclofenac
- Any woman with special postpartum pain relief plan such as sickle cell disease patient
- Preeclamptic/eclamptic, renal and liver diseases patients.
- Parturient on epidural anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480001, Nigeria
Federal Teaching Hospital, Abakaliki
Abakaliki, Ebonyi State, 480001, Nigeria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 14, 2024
First Posted
January 23, 2024
Study Start
June 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
January 23, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share