Clinical Trial: The Effect of Pain Medication in Children With Acute Abdominal Pain and Its Implication Over the Surgeon's Decision
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Effect of Opiate Administration in Children With Acute Abdominal Pain and Peritoneal Signs on the Decision for Surgical Intervention
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 Summary:
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
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: 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. [ Time Frame: 2 Hours post-medication ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis. [ Time Frame: 2 weeks ]
Original Secondary Outcome: Same as current
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: February 6, 2009
Date Started: December 2008
Date Completion: December 2010
Last Updated: February 9, 2009
Last Verified: February 2009
