Morphine Analgesia in Patients With Acute Appendicitis

Appendicitis Clinical Trial

Official title:

Double Blind Randomized Study of Morphine Analgesia in Patients With Acute Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477061
• Other study ID #: AG11
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2007
• Last updated: May 20, 2007
• Start date: January 2004
• Est. completion date: March 2005

Study information

• Verified date: May 2007
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.

Description:

Analgesic administration for pain control in patients with acute abdominal pain, regarding acute appendicitis, is controversial. Despite the results previous studies indicating the safeness of analgesic use in ED for acute abdominal pain, physicians still prefer to postpone their use after performing surgical evaluations. Since many patients admitted to ED are unlikely to receive prompt surgical consultation, many of them need pain relief to prevent unnecessary suffering. On the other hand such pain relief must not interfere with the diagnosis and treatment of patients and do not cause any complications. Morphine is a common and effective analgesic which, if shown to have no effect on correct diagnosis of acute abdomen, can be used for this purpose.

Thus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients admitted to ED with the diagnosis of acute appendicitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 75 Years

Eligibility

Inclusion Criteria:

• clinical signs of acute appendicitis

• planned for appendectomy

• supposed to wait for at least 1 hour in the ED before operation

Exclusion Criteria:

• suspicion to perforated appendicitis

• being under the age of 13

• pregnancy (according to history and ß-HCG result)

• opium addiction

• systolic blood pressure of less than 90 mmHG

• known cases of chronic obstructive pulmonary disease (COPD)

• known sensitivity to morphine

• history of sickle cell disease

• self administration of analgesics before enrollment

• refusal to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Morphine

Locations

Country	Name	City	State
Iran, Islamic Republic of	Sina General Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity
Secondary	Diagnostic Accuracy