The Effect of Pain Medication in Children With Acute Abdominal Pain and Its Implication Over the Surgeon's Decision

NCT00839787 | Withdrawn

• 1 other identifier: 200901230503p
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Surgeons are the individuals who will operate on a patient if it is determined to be necessary after they present with abdominal pain. For that reason, the investigators want to study if giving a medicine (morphine) to children presenting to the ED with abdominal pain will alleviate pain without changing the patient's physical exam and the subsequent surgeon's decision. The investigators also will record any side effects of morphine, any associated surgical complications, and to identify the ultimate diagnosis.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• To demonstrate that IV morphine will alleviate pain in children presenting to the Emergency Department with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.

  2 Hours post-medication

Secondary Outcomes (1)

• Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis.

  2 weeks

Study Arms (2)

Morphine

EXPERIMENTAL

Morphine Sulfate: If weight is \<50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given.

Drug: Morphine Sulfate

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Morphine Sulfate

Interventions

Morphine Sulfate DRUG

Morphine Sulfate group: If weight is \<50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given

Also known as: Astramorph,Avinza,DepoDur,Duramorph,Infumorph,Kadian

Morphine; Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 1 to18 years of age who present with acute abdominal pain and signs of peritoneal irritation of less than 5 days duration.
• Pain scores from moderate to severe
• Need for intravenous access and require surgical consultation.

You may not qualify if:

• Pregnancy
• Chronic pain (defined as pain of more than two weeks' duration). 3. Constipation (Bowel movement less than 3imes/week, hard, small, or difficult to eliminate)
• Prior abdominal surgery or traumatic abdominal pain.
• History of gastritis, peptic ulcer disease, gastro esophageal reflux disease.
• Chronic illnesses associated with pain such as Ulcerative colitis, Crohn's disease, sickle cell disease or altered perception to pain (autism, spina bifida, altered mental status).
• Previous use of morphine sulfate or other narcotic/medication known to alter pain
• Perception or mental status six hours prior to presentation in the ED.
• Prior allergy or anaphylaxis to morphine.
• Acute respiratory distress, hypotension (less than 5thpercentile for age).
• Renal, pancreatic or biliary disease

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mercedes M Uribe, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

US (1)