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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00839787
First received: February 6, 2009
Last updated: February 9, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Abdominal Pain
Drug: Morphine Sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Opiate Administration in Children With Acute Abdominal Pain and Peritoneal Signs on the Decision for Surgical Intervention

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine
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
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
Other Name: Astramorph,Avinza,DepoDur,Duramorph,Infumorph,Kadian
Placebo Comparator: Placebo
Normal saline
Drug: Morphine Sulfate
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
Other Name: Astramorph,Avinza,DepoDur,Duramorph,Infumorph,Kadian

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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839787

Locations
United States, Texas
Children's Medical Center at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Mercedes M Uribe, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Mercedes Uribe/MD., UT Southwestern
ClinicalTrials.gov Identifier: NCT00839787     History of Changes
Other Study ID Numbers: 200901230503p
Study First Received: February 6, 2009
Last Updated: February 9, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014