Perforated AppendicitisNCT02881996
The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis
A study testing IV tylenol, No IV tylenol and Ketorolac in people with Perforated Appendicitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- IV tylenol, No IV tylenol and Ketorolac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Perforated Appendicitis
- Being tested
- IV tylenol, No IV tylenol, Ketorolac
- Keywords
- appendicitis, pain, perforation
- Medical subject headings
- Appendicitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV tylenolDrug
Also called acetaminophen,
IV tylenol given scheduled in addition to standard PCA
No IV tylenolDrug
No additional IV Tylenol given
KetorolacDrug
Also called toradol
both groups receive as part of our standard postop pain protocol after all operations
| Study group | Role | What they receive |
|---|---|---|
| IV tylenol | Experimental | 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. Receives: Drug: IV tylenol; Drug: Ketorolac |
| No IV tylenol | Active comparator | Same as above without IV tylenol. Receives: Drug: No IV tylenol; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until PCA Discontinued After the Operation
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.
Measured: 4 days
Secondary outcomes (1)
Postoperative Duration of Hospital Stay
The investigators will measure postoperative time to discharge
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881996
- Sponsor's protocol ID
- 13100328
- Status last verified
- Dec 2020
- First submitted
- 18 Jan 2016
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02881996
- Acronym / sponsor ID
- 13100328
- Conditions
- Perforated Appendicitis
- Keywords
- appendicitis, pain, perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV tylenol | Experimental | Drug: IV tylenol, Drug: KetorolacPost-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. |
| No IV tylenol | Active comparator | Drug: No IV tylenol, Drug: KetorolacSame as above without IV tylenol. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV tylenolAlso: acetaminophen,IV tylenol given scheduled in addition to standard PCA | Drug | IV tylenol |
| No IV tylenolNo additional IV Tylenol given | Drug | No IV tylenol |
| KetorolacAlso: toradolboth groups receive as part of our standard postop pain protocol after all operations | Drug | IV tylenol, No IV tylenol |
Primary outcome
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.
1 secondary outcome
Postoperative Duration of Hospital Stay
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Perforated Appendicitis
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Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
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Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV tylenol, No IV tylenol and Ketorolac in people with Perforated Appendicitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Until PCA Discontinued After the Operation (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.