Diclofenac Sodium 50Mg Suppository
DrugOther names: Voltaren 50Mg Suppository
NCT Number: NCT03041779
To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.
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Interventional
Phase 2
Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. Therefore, In view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stage 1:
a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery
Stage 2:
Exclusion criteria
Stage 1:
Stage 2:
Other names: Voltaren 50Mg Suppository
Other names: Acetaminophen 500Mg Suppository
Time frame: at 2nd to 3rd hour post repair
Time frame: immediate after delivery
Time frame: immediate post perineum repair
Time frame: at 5th to 6th hour post repair
Time frame: prior to discharge
Clinical Research Centre, Malaysia
Other
A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth
Acronym: SuPPerP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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