Oral or rectal, diclofenac or paracetamol for the relief of perineal pain after childbirth: a randomised controlled trial.

A randomised controlled trial comparing pain scores for rectal Diclofenac with oral Diclofenac and oral or rectal Paracetamol in primiparous women after childbirth.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000555257

Enrollment

240

Registered

2009-07-08

Start date

2004-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study provides evidence of the effectiveness of both the most commonly used analgesics (Diclofenac and Panadol), and the mode of administration (oral or rectal), in relieving perineal pain after childbirth. We hypothesised that: 1. Regular oral analgesia is equally as effective as rectal analgesia in relieving perineal pain after childbirth. 2. Diclofenac is more effective an analgesia than Panadol. 3. Women prefer oral analgesia to rectal analgesia.

Interventions

Control Group, Group 1: Rectal diclofenac 100mg every 12 hours for 48 hours, Group 2: Rectal paracetamol 1g every 6 hours for 48 hours, Group 3: Oral diclofenac 50mg every 8 hours for 48 hours, Group 4: Oral paracetamol 1g every 6 hours for 48 hours

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Primiparous women who have a second-degree tear or greater or an episiotomy after a vaginal birth.

Exclusion criteria

Contraindications to non-steroidal anti-inflammatory medications History of gastrointestinal ulcer or bleeding Significant renal or liver impairment Preeclampsia and essential hypertension. Asthma Postpartum haemorrhage greater than 1000mL Medical disorders associated with a disturbed coagulation profile, in particular immune thrombocytopenic purpura, disseminated intravascular coagulation Women of non-English speaking background Women taking anticoagulants, Lithium, Digoxin, Chloramphenicol or diuretics

Outcome results