AppendicitisPhase 1/2NCT03528343
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
A Phase 1/2 study of Appendicitis and Pain, Postoperative, run by University of Utah at 1 site in United States.
Trial summary
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Appendicitis, Pain, Postoperative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 1 Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ages 0 to 18 years old
- Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)
Who cannot join
- Patients on chronic opioids
- Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
Official title: Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.
Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.
The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
Read the detailed description
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.
Children admitted after undergoing surgical management for a diagnosis of acute appendicitis will be randomized at discharge to a narcotic arm or a tylenol/motrin arm. The narcotic arm will receive the standard of care narcotic prescription. The tylenol/motrin arm will receive education to use tylenol and motrin for pain control as well as a paper prescription provided for the sole purpose of rescue.
Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.
The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
- Conditions
- Appendicitis, Pain, Postoperative
- Being tested
- Non-narcotic pain control
- Keywords
- appendicitis, postoperative pain, patient satisfaction, children, pediatric, narcotic, pain control
- Medical subject headings
- Appendicitis, Pain, Postoperative, Patient Satisfaction, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-narcotic pain controlDrug
Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.
| Study group | Role | What they receive |
|---|---|---|
| Tylenol/Motrin | Experimental | Group of patients who will receive instructions to use tylenol and motrin for pain control, and parents will be sent home with a paper prescription with a rescue does of standard of care narcotics. They will be instructed to only use the rescue dose if pain is uncontrolled using over the counter medications. Receives: Drug: Non-narcotic pain control |
| Narcotic | No intervention | Group of patients who will receive the standard of care narcotic prescription filled upon discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)
Measured: 2-week follow-up visit
Secondary outcomes (6)
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by Parental Post-operative Pain Measure (PPPM)
Measured: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)
Patient satisfaction with pain control at home following pediatric appendectomy as assessed by an adaptation of Parental Post-operative Pain Measure (PPPM)
Measured: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient pain scores using Wong-Baker Faces Pain Rating Scale
Patient description of pain control using validated Wong-Baker Faces Pain Rating Scale. This scale presents the subject with a series of 6 depictions of faces and a text description of pain level. The range is from 0 "No Hurt" to 10 "Hurts Worst".
Measured: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Number of pain medications used
Number of pain medications used
Measured: Post-operative days 1-14 (until follow-up)
Days of pain medication requirement after discharge
Number of days patient required pain medication
Measured: Post-operative days 1-14 (until follow-up)
Number of pain medication side effects
Side effects experienced by taking pain medications following surgery
Measured: Post-operative days 1-14 (until follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start5 Sep 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Why it stopped: Lost research support for enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Primary Children's Hospital
- Responsible party
- Principal investigator, Sean Stokes, University of Utah
- Investigators
- Stephen J Fenton, MD, Principal investigator, University of Utah, Primary Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528343
- Sponsor's protocol ID
- UU83426
- Status last verified
- Feb 2020
- First submitted
- 12 Sep 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blakely ML, Spurbeck WW, Lobe TE. Current status of laparoscopic appendectomy in children. Semin Pediatr Surg. 1998 Nov;7(4):225-7. doi: 10.1016/s1055-8586(98)70035-6.
PubMed 9840903Buckius MT, McGrath B, Monk J, Grim R, Bell T, Ahuja V. Changing epidemiology of acute appendicitis in the United States: study period 1993-2008. J Surg Res. 2012 Jun 15;175(2):185-90. doi: 10.1016/j.jss.2011.07.017. Epub 2011 Aug 9.
PubMed 22099604Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
PubMed 21958060Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
PubMed 8867249Alkhoury F, Knight C, Stylianos S, Zerpa J, Pasaron R, Mora J, Aserlind A, Malvezzi L, Burnweit C. Prospective Comparison of Nonnarcotic versus Narcotic Outpatient Oral Analgesic Use after Laparoscopic Appendectomy and Early Discharge. Minim Invasive Surg. 2014;2014:509632. doi: 10.1155/2014/509632. Epub 2014 Apr 14.
PubMed 24834350Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
PubMed 14527704Abou-Karam M, Dube S, Kvann HS, Mollica C, Racine D, Bussieres JF, Lebel D, Nguyen C, Thibault M. Parental Report of Morphine Use at Home after Pediatric Surgery. J Pediatr. 2015 Sep;167(3):599-604.e1-2. doi: 10.1016/j.jpeds.2015.06.035. Epub 2015 Jul 21.
PubMed 26205183Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.
PubMed 24112856Alkhoury F, Malvezzi L, Knight CG, Diana J, Pasaron R, Mora J, Aserlind A, Stylianos S, Burnweit C. Routine same-day discharge after acute or interval appendectomy in children: a prospective study. Arch Surg. 2012 May;147(5):443-6. doi: 10.1001/archsurg.2012.132.
PubMed 22785642Stessel B, Theunissen M, Fiddelers AA, Joosten EA, Kessels AG, Gramke HF, Marcus MA. Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial. Curr Ther Res Clin Exp. 2014 Nov 28;76:120-5. doi: 10.1016/j.curtheres.2014.10.001. eCollection 2014 Dec.
PubMed 25516773
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03528343
- Acronym / sponsor ID
- UU83426
- Conditions
- Appendicitis, Pain, Postoperative
- Keywords
- appendicitis, postoperative pain, patient satisfaction, children, pediatric, narcotic, pain control
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lost research support for enrolling patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Primary Children's Hospital
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.
Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.
The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
Detailed description
There is concern that pain prescription after outpatient pediatric surgical procedures is excessive and is in excess of patient need. Current practice following pediatric appendectomy is to prescribe all children with 5-15 doses of narcotic pain medication upon discharge regardless of their age, severity of appendicitis, or pain control in the hospital. This study examines the amount of narcotic pain control required by pediatric patients after undergoing appendectomy using a randomized controlled trial study design.
Children admitted after undergoing surgical management for a diagnosis of acute appendicitis will be randomized at discharge to a narcotic arm or a tylenol/motrin arm. The narcotic arm will receive the standard of care narcotic prescription. The tylenol/motrin arm will receive education to use tylenol and motrin for pain control as well as a paper prescription provided for the sole purpose of rescue.
Pain control will be assessed with a post-operative pain scale, patient satisfaction survey, and parent satisfaction survey on the days following surgery and at post-operative follow-up.
The hypothesis is that the pain scores and patient satisfaction surveys will show no difference in post-operative pain control between the two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tylenol/Motrin | Experimental | Drug: Non-narcotic pain controlGroup of patients who will receive instructions to use tylenol and motrin for pain control, and parents will be sent home with a paper prescription with a rescue does of standard of care narcotics. They will be instructed to only use the rescue dose if pain is uncontrolled using over the counter medications. |
| Narcotic | No intervention | –Group of patients who will receive the standard of care narcotic prescription filled upon discharge. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children ages 0 to 18 years old
- Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)
Key exclusion criteria (3 listed)
- Patients on chronic opioids
- Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication
- Pregnancy
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 |
|---|---|---|
| Non-narcotic pain controlEducation to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided. | Drug | Tylenol/Motrin |
Primary outcome
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Time frame: 2-week follow-up visit
Parental satisfaction with pain control at home following pediatric appendectomy as assessed by the validated Parental Post-operative Pain Measure (PPPM)
6 secondary outcomes
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)
Time frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient pain control satisfaction using adaptation of Parental Post-operative Pain Measure (PPPM)
Time frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Patient pain scores using Wong-Baker Faces Pain Rating Scale
Time frame: Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Number of pain medications used
Time frame: Post-operative days 1-14 (until follow-up)
Days of pain medication requirement after discharge
Time frame: Post-operative days 1-14 (until follow-up)
Number of pain medication side effects
Time frame: Post-operative days 1-14 (until follow-up)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 9840903Blakely ML, Spurbeck WW, Lobe TE. Current status of laparoscopic appendectomy in children. Semin Pediatr Surg. 1998 Nov;7(4):225-7. doi: 10.1016/s1055-8586(98)70035-6.
- Background: PubMed 22099604Buckius MT, McGrath B, Monk J, Grim R, Bell T, Ahuja V. Changing epidemiology of acute appendicitis in the United States: study period 1993-2008. J Surg Res. 2012 Jun 15;175(2):185-90. doi: 10.1016/j.jss.2011.07.017. Epub 2011 Aug 9.
- Background: PubMed 21958060Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background: PubMed 8867249Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.
- Background: PubMed 24834350Alkhoury F, Knight C, Stylianos S, Zerpa J, Pasaron R, Mora J, Aserlind A, Malvezzi L, Burnweit C. Prospective Comparison of Nonnarcotic versus Narcotic Outpatient Oral Analgesic Use after Laparoscopic Appendectomy and Early Discharge. Minim Invasive Surg. 2014;2014:509632. doi: 10.1155/2014/509632. Epub 2014 Apr 14.
- Background: PubMed 14527704Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
- Background: PubMed 26205183Abou-Karam M, Dube S, Kvann HS, Mollica C, Racine D, Bussieres JF, Lebel D, Nguyen C, Thibault M. Parental Report of Morphine Use at Home after Pediatric Surgery. J Pediatr. 2015 Sep;167(3):599-604.e1-2. doi: 10.1016/j.jpeds.2015.06.035. Epub 2015 Jul 21.
- Background: PubMed 24112856Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.
- Background: PubMed 22785642Alkhoury F, Malvezzi L, Knight CG, Diana J, Pasaron R, Mora J, Aserlind A, Stylianos S, Burnweit C. Routine same-day discharge after acute or interval appendectomy in children: a prospective study. Arch Surg. 2012 May;147(5):443-6. doi: 10.1001/archsurg.2012.132.
- Background: PubMed 25516773Stessel B, Theunissen M, Fiddelers AA, Joosten EA, Kessels AG, Gramke HF, Marcus MA. Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial. Curr Ther Res Clin Exp. 2014 Nov 28;76:120-5. doi: 10.1016/j.curtheres.2014.10.001. eCollection 2014 Dec.
- Individual participant dataSharing planned: No
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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.
Stephen J Fenton, MD principal investigator
University of Utah, Primary Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Appendicitis and Pain, Postoperative, run by University of Utah 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Feb 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM) (time frame: 2-week follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528343, which also lists 11 linked publications.
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 7 Feb 2020.