Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

Pain, Postoperative Clinical Trial

Official title:

Comparing Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03528343
• Other study ID #: UU83426
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 5, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children ages 0 to 18 years old

• Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)

Exclusion Criteria:

• Patients on chronic opioids

• Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication

• Pregnancy

Related Conditions & MeSH terms

• Appendicitis
• Pain, Postoperative

Intervention

Drug:
• Non-narcotic pain control
Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.

Locations

Country	Name	City	State
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Primary Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (11)

Abou-Karam M, Dubé S, Kvann HS, Mollica C, Racine D, Bussières 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. — View Citation

Alkhoury 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. — View Citation

Alkhoury 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. — View Citation

Blakely ML, Spurbeck WW, Lobe TE. Current status of laparoscopic appendectomy in children. Semin Pediatr Surg. 1998 Nov;7(4):225-7. — View Citation

Buckius 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. — View Citation

Chambers CT, Finley GA, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-43. — View Citation

Finley GA, McGrath PJ, Forward SP, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-7. — View Citation

Gerbershagen 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. — View Citation

Liu 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. — View Citation

Stessel 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. — View Citation

Tomecka 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2-week follow-up visit
Secondary	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)	Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Secondary	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)	Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Secondary	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".	Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up
Secondary	Number of pain medications used	Number of pain medications used	Post-operative days 1-14 (until follow-up)
Secondary	Days of pain medication requirement after discharge	Number of days patient required pain medication	Post-operative days 1-14 (until follow-up)
Secondary	Number of pain medication side effects	Side effects experienced by taking pain medications following surgery	Post-operative days 1-14 (until follow-up)