Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain

Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01465984

Enrollment

Registered

2011-11-07

Start date

2011-11-30

Completion date

2012-12-31

Last updated

2012-12-10

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

Conditions

Acute Pain

Keywords

Paracetamol, Morphine sulfates, Acute pain

Brief summary

The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.

Detailed description

Limb trauma is a painful condition that requires urgent analgesic treatment . Intravenous Opioids and NSAIDs are used extensively to control pain; both of them are with side effects. Paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than Morphine and NSAIDs, and approved as a safe and effective analgesic in emergency department. recently Iv Paracetamol has become available in European countries and also in Iran. efficacy and safety of IV Paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation. Therefore, the investigators want to study the efficacy of IV Paracetamol in limb trauma and compare it with Iv Morphine sulfate.

Interventions

DRUGParacetamol

paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of acute limb trauma * Age\>=18 years * Acute pain of score 3 or greater on visual analogue scale

Exclusion criteria

* Unstable hemodynamic (Systolic blood pressure under 90 mmHg) * Known sensitivity to opioids or paracetamol * Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction) * Previous administration of analgesic during 6 hours ago * Pregnant women * previous inclusion to the study * diagnosed heart failure * renal failure * pulmonary failure or hepatic failure

Design outcomes

Primary

Measure	Time frame
Change in pain severity/score	after 30 minutes

Secondary

Measure	Time frame
Need for rescue analgesia	After 30 minutes

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026