Management of Post-Tonsillectomy Pain in Pediatric Patients

Pain, Postoperative Clinical Trial

Official title:

Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551196
• Other study ID #: 202002118
• Status: Completed
• Phase: Phase 3
• Start date: September 28, 2020
• Est. completion date: November 10, 2022

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• 4 to 17 years of age at time of enrollment
• Undergoing tonsillectomy with or without adenoidectomy
• Able to provide informed consent from parent or legal guardian
• Able to provide assent if subject is a minor of appropriate age

Exclusion Criteria:

• Allergy to acetaminophen or ibuprofen
• Inability for study participant to cooperate with pain assessments
• Known pregnancy
• Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Related Conditions & MeSH terms

• Hypertrophy
• Pain, Postoperative
• Tonsillar Hypertrophy
• Tonsillitis

Intervention

Drug:
• Alternating Acetaminophen and Ibuprofen
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
• Combined Acetaminophen and Ibuprofen
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.

Locations

Country	Name	City	State
United States	Saint Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (15)

Alvarez Palacios I, Gonzalez-Orus Alvarez-Morujo R, Alonso Martinez C, Ayala Mejias A, Arenas Britez O. Postoperative Pain in Adult Tonsillectomy: Is There Any Difference Between the Technique? Indian J Otolaryngol Head Neck Surg. 2017 Jun;69(2):187-193. doi: 10.1007/s12070-017-1058-9. Epub 2017 Jan 16. — View Citation

D'Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int J Pediatr Otorhinolaryngol. 2015 Sep;79(9):1472-6. doi: 10.1016/j.ijporl.2015.05.042. Epub 2015 Jul 2. — View Citation

Gardiner P, Dvorkin L. Promoting medication adherence in children. Am Fam Physician. 2006 Sep 1;74(5):793-8. — View Citation

Haynes RB, McKibbon KA, Kanani R. Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet. 1996 Aug 10;348(9024):383-6. doi: 10.1016/s0140-6736(96)01073-2. Erratum In: Lancet 1997 Apr 19;349(9059):1180. — View Citation

Ingram DG, Friedman NR. Toward Adenotonsillectomy in Children: A Review for the General Pediatrician. JAMA Pediatr. 2015 Dec;169(12):1155-61. doi: 10.1001/jamapediatrics.2015.2016. — View Citation

Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US Pharm. 41, 31-34 (2016).

Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906. — View Citation

Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813-27. doi: 10.1016/j.ijporl.2014.08.011. Epub 2014 Aug 27. — View Citation

Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3. — View Citation

Merry AF, Gibbs RD, Edwards J, Ting GS, Frampton C, Davies E, Anderson BJ. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):80-8. doi: 10.1093/bja/aep338. — View Citation

Miranda HF, Puig MM, Prieto JC, Pinardi G. Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain. Pain. 2006 Mar;121(1-2):22-8. doi: 10.1016/j.pain.2005.11.012. Epub 2006 Feb 9. — View Citation

Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757. — View Citation

National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/

Tobias JD, Green TP, Cote CJ; SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE; COMMITTEE ON DRUGS. Codeine: Time to Say "No". Pediatrics. 2016 Oct;138(4):e20162396. doi: 10.1542/peds.2016-2396. Epub 2016 Sep 19. — View Citation

Uitti JM, Salantera S, Laine MK, Tahtinen PA, Ruohola A. Adaptation of pain scales for parent observation: are pain scales and symptoms useful in detecting pain of young children with the suspicion of acute otitis media? BMC Pediatr. 2018 Dec 20;18(1):392. doi: 10.1186/s12887-018-1361-y. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of FLACC pain scores =7 from POD 1 through POD 3	The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores =7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens.; The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.	up to 3 days following consent
Secondary	Proportion of FLACC pain scores =7 on each individual POD 1, 3, and 7	The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores =7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens.; The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.	3 separate individual days, will be completed days after the surgery
Secondary	Proportion of cumulative FLACC pain scores =7 from POD 1 through POD 7	The proportion of cumulative FLACC pain scores =7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens.; The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.	up to 7 days following consent
Secondary	Proportion of Faces pain scores =8 on POD 1, 3, and 7	The proportion of Faces pain scores =8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens.; The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.	3 separate individual days, will be completed days after the surgery
Secondary	Proportion of cumulative Faces pain scores =8 from POD 1 through POD 7	The proportion of cumulative Faces pain scores =8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens.; The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.	up to 7 days following consent
Secondary	Rescue Medication Usage through POD 3	The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.	up to 3 days following consent
Secondary	Rescue Medication Usage through POD 7	The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.	up to 7 days following consent
Secondary	Proportion of subjects that adhere to the assigned medication regimen	Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.	up to 3 days following consent
Secondary	Adverse Events	Incidence of adverse events	up to 7 days following consent