Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy

NCT03528343 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: UU83426
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Appendicitis; Pain, Postoperative

Keywords

appendicitis; postoperative pain; patient satisfaction; children; pediatric; narcotic; pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Parental pain control satisfaction using Parental Post-operative Pain Measure (PPPM)

  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)

  Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up

• Patient pain scores using Wong-Baker Faces Pain Rating Scale

  Changes from in-hospital, days 1-3 following discharge, and 2-week follow-up

• Number of pain medications used

  Post-operative days 1-14 (until follow-up)

• Days of pain medication requirement after discharge

  Post-operative days 1-14 (until follow-up)

Study Arms (2)

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.

Drug: Non-narcotic pain control

Narcotic

NO INTERVENTION

Group of patients who will receive the standard of care narcotic prescription filled upon discharge.

Interventions

Non-narcotic pain control DRUG

Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.

Tylenol/Motrin

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children ages 0 to 18 years old
• Patients have undergone appendectomy by any technique (open, laparoscopic, single-port)

You may not qualify if:

• Patients on chronic opioids
• Patient undergoes a more extensive or additional procedures at the time of operation due to complications or other indication
• Pregnancy

Sponsors & Collaborators

• University of Utah: lead
• Primary Children's Hospital: collaborator

Study Sites (1)

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Related Publications (11)

• 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.

  PMID: 9840903 BACKGROUND

• 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.

  PMID: 22099604 BACKGROUND

• 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.

  PMID: 21958060 BACKGROUND

• 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.

  PMID: 23392233 BACKGROUND

• Finley 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.

  PMID: 8867249 BACKGROUND

• 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.

  PMID: 24834350 BACKGROUND

• Chambers 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.

  PMID: 14527704 BACKGROUND

• Abou-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.

  PMID: 26205183 BACKGROUND

• 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.

  PMID: 24112856 BACKGROUND

• 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.

  PMID: 22785642 BACKGROUND

• 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.

  PMID: 25516773 BACKGROUND

MeSH Terms

Conditions

Appendicitis; Pain, Postoperative; Patient Satisfaction; Agnosia

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Stephen J Fenton, MD

  University of Utah, Primary Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: May 17, 2018
• Study Start: September 5, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)