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Trial record 58 of 1877 for:    ACETAMINOPHEN

The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis

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ClinicalTrials.gov Identifier: NCT02881996
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Brief Summary:
The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (PCA) to oral pain medications.

Condition or disease Intervention/treatment Phase
Perforated Appendicitis Drug: IV tylenol Drug: No IV tylenol Drug: Ketorolac Not Applicable

Detailed Description:

To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission.

Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Experimental: IV tylenol
Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.
Drug: IV tylenol
IV tylenol given scheduled in addition to standard PCA
Other Name: acetaminophen,

Drug: Ketorolac
both groups receive as part of our standard postop pain protocol after all operations
Other Name: toradol

Active Comparator: No IV tylenol
Same as above without IV tylenol.
Drug: No IV tylenol
No additional IV Tylenol given

Drug: Ketorolac
both groups receive as part of our standard postop pain protocol after all operations
Other Name: toradol




Primary Outcome Measures :
  1. Time until PCA discontinued after the operation [ Time Frame: 4 days ]
    The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications.


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: 1 week ]
    The investigators will measure time to discharge



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.

Exclusion Criteria:

  • Non-perforated appendicitis
  • Normal appendix at the time of operation or other associated conditions causing abdominal pain
  • Patients with history of chronic pain
  • Known underlying liver disorders
  • Known allergy to pain medication in protocol
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881996


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City

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Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02881996     History of Changes
Other Study ID Numbers: 13100328
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Children's Mercy Hospital Kansas City:
appendicitis
pain
perforation
Additional relevant MeSH terms:
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Acetaminophen
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Ketorolac
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action