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A prospective, double-blind, double-dummy, randomised controlled trial to compare pain relief from intravenous paracetamol and oral paracetamol in acute pain patients presenting to the Emergency Department

A prospective, double-blind, double-dummy, randomised controlled trial to compare pain relief from intravenous paracetamol and oral paracetamol in acute pain patients presenting to the Emergency Department

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000481572
Enrollment
100
Registered
2015-05-15
Start date
2015-04-24
Completion date
2016-02-22
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

Randomised control trial of IV and oral paracetamol to assess the efficacy of pain relief. This project could act as a pilot study to form a basis for more extensive research to support the introduction of IV paracetamol for certain ED populations We hypothesize that patients receiving the IV paracetamol will have a more rapid reduction in pain score, larger reduction in pain scores and require less rescue analgesia than patients in the oral paracetamol group.

Interventions

Arm 1: paracetamol 1 gram, intravenous as a single dose Arm 2: paracetamol 1 gram, oral as a single dose

Sponsors

The Townsville Hospital and Health Service
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age greater than or equal to 18years Already has intravenous access or has a clinical condition indicating that intravenous access is required Have received at least one initial dose of morphine (either with Queensland Ambulance Service or in ED) with ongoing pain score >40mm on the Visual Analogue Scale (VAS) at > 5 minutes post administration of morphine or equivalent.

Exclusion criteria

Any state (e.g. intoxicated) or medical history (e.g. mental health disorder) impairing accurate pain assessment Known/suspected to have drug dependence Allergic to paracetamol Received or taken paracetamol in the last 6 hours Known or suspected Renal or hepatic insufficiency Pregnant Currently enrolled in other clinical trials for the treatment of pain Unable to safely swallow oral medication

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026