Clinical trial NCT00839787: The Effect of Pain Medication in Children With Acute Abdominal Pain and Its Implication Over the Surgeon's Decision
Official title: The Effect of Opiate Administration in Children With Acute Abdominal Pain and Peritoneal Signs on the Decision for Surgical Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdominal Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Unfortunately, the current standard of care obviates the use of pain medication in children with acute abdominal pain while waiting for the attending pediatric surgeon to perform their examination and determine if the patient requires operative intervention. This process can sometimes be protracted.

This practice occurs currently because of the concerns that analgesia may alter physical findings, interfere with the diagnosis, and delay definitive surgical intervention resulting in increased morbidity. This point of view has been challenged recently.

We designed this study taking into account the paramount importance of the pediatric surgeon's role in determining the need for operative intervention in the ultimate management of patient's presenting with acute abdominal pain and signs and symptoms of peritonitis.

Our primary objective is to demonstrate that the administration of intravenous morphine will alleviate pain in children presenting to the Emergency Department (ED) with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.

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

This is a prospective, randomized double-blind, placebo-controlled clinical that will be conducted in the ED at Children's Medical Center of Dallas. Children aged 1 to 18 years with acute abdominal pain of ≤ 3 days duration, a moderate to severe pain score, and the presence of peritoneal signs will be eligible. Patients will be randomized to receive either 0.1mg/kg of intravenous morphine (maximum 10 mg) or an equal volume of placebo (0.9% saline).

An ED physician will obtain clinical data, determine the pain score, write a presumptive diagnosis and place an order for the study medication. A surgical physician will also obtain clinical data and write his/her disposition. This evaluation will be repeated at 30-120 minutes after administration of the study medication by the ED and surgical physicians.

Each subject will be monitored for 2 weeks after enrollment for follow-up.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 2 Hours post-medication
Secondary outcomes:
measure: Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Mercedes M Uribe, MD
role: PRINCIPAL_INVESTIGATOR
References: