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Intravenous Morphine sulfate versus nebulized Fentanyl in patients with acute pain.

Effect of nebulized Fentanyl in relief pain due to acute limb trauma and comparing it with intravenous Morphine sulfate.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012111710585N1
Enrollment
90
Registered
2013-03-20
Start date
2012-11-19
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Acute limb trauma. Superficial injury to shoulder and upper arm, Open wound of shoulder and upper arm, fracture of shoulder and upper arm, Dislocation, sprain and strain of joints and ligaments of shoulder girdle, Superficial injury of forearm, Open wound of forearm, Fractu

Interventions

Intervention 1: In group 1 or intervention group patients received drug and placebo in 2 syringes that were filled by study headmaster. Both of the syringes contained 10 milliliter of clear liquid. Sy
build in Iranian drug industry (Daroupakhsh or Abureihan) that diluted to 1 milligram/milliliter for intravenous injection. Intra venous Morphine sulfate prescribed by dose of 0.1 milliliter/kilogram
Treatment - Drugs
In group 1 or intervention group patients received drug and placebo in 2 syringes that were filled by study headmaster. Both of the syringes contained 10 milliliter of clear liquid. Syringe number 1
In group 2 or control group patients received drugs in 2 syringes that were filled by study headmaster and both of them contained 10 milliliters of clear liquid. Syringe number 1 contains 10 millilit

Sponsors

The vice chancellor for research,The medical school of Tehran University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all patients who presented to our ED and were complaining pain due to acute limb trauma with severity index of pain at least 5 of 10 in Numerical Pain Score (NRS). Exclusion criteria: special group of patients (pregnant, breast feeding); history of respiratory disease such as asthma; patients who were receiving neuroleptic drugs; patients with chronic pain, opium or alcohol addiction or chronic use of analgesics.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain score which is reported by patient. Timepoint: Five, 10, 15, 30 and 60 minutes after receiving drugs. Method of measurement: Questionnaire by Numerical Pain Scale(NRS).

Secondary

MeasureTime frame
Respiratory rate. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire.;Patient's Global rating of satisfaction. Timepoint: One hour after receiving drug via nebulizer. Method of measurement: Questionnaire.;The period of time between treatment and the onset of analgesia. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire.;Total dose of rescue dose of Morphine sulfate. Timepoint: Since 15 minutes after receiving drug via nebulizer. Method of measurement: milligram.;The percentage of arterial Oxygen saturation. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Percent.;Systolic and diastolic blood pressure. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: millimeter of mercury.;Heart rate. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Beat per minute.;Level of consciousness. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire.;The number of reported nausea or vomiting. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shervin Farahmand

Tehran University of Medical Science

shfarahmand@sina.tums.ac.ir+98 21 6690 4848

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026