Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

NCT02727491 | Completed Phase 4

• 1 other identifier: ANAE-182-10
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

With Institutional ethics board and Health Canada approval, pediatric patients (ages 3-12) undergoing tonsillectomy or adenotonsillectomy (under standardized anesthesia) will be randomized to receive dextromethorphan hydrobromide (1mg/kg orally) 30 min preoperatively and again 8 hours postoperatively OR placebo (syrup identical in taste, appearance and volume) at the same time points. The primary outcome is an integrated assessment of perioperative pain scores and opioid use for 24 hours postoperatively. Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding for 24 hours postoperatively. Our hypothesis is that dextromethorphan will decrease the incidence/severity of post-tonsillectomy pain. The improved pain control will be apparent through reduced opioid consumption and integrated pain scores. This will result in a reduced incidence of opioid-related side effects and adverse events.

Conditions

Pain, Postoperative

Keywords

opioid analgesics,; opioid consumption; adverse effects; postoperative pain; tonsillectomy

Outcome Measures

Primary Outcomes (1)

• integrated assessment of pain scores and opioid use

  The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) will be measured at rest 24 hours postoperatively and this will be integrated with total opioid consumption at 24 hours postoperatively. This will be achieved by converting both pain scores and opioid consumption to % change. The % differences for each of the 2 variables are then added together on a per-subject basis to provide a summated % difference. The individual and summated % differences can then be plotted on a single graph and the integrated ranks of the experimental and control groups can be compared with standard statistical tests.(1)

  24 hours postoperatively

Secondary Outcomes (2)

• opioid-related adverse effects

  up to 24 hours postoperatively

• pain scores

  1,2,3,8,9 and 10 hours postoperatively

Study Arms (2)

dextromethorphan

EXPERIMENTAL

1 mg/kg of dextromethorphan syrup orally 30 min preoperatively and then again 8 hours post-tonsillectomy

Drug: Dextromethorphan

Placebo

PLACEBO COMPARATOR

30 min preoperatively and then again 8 hours postoperatively, received inactive placebo syrup identical in volume, appearance and taste as the experimental group

Drug: Placebo

Interventions

Dextromethorphan DRUG

Dextromethorphan is a drug of the morphinan class with sedative, dissociative, and stimulant properties (at higher doses). Dextromethorphan has been explored for a number other uses in medicine, including pain relief (as either the primary analgesic, or an opioid potentiator).

Also known as: dextromethorphan hydrobromide

dextromethorphan

Placebo DRUG

Placebo syrup identical to active comparator in taste, appearance and volume but is inactive. Placebo comparator will be used in the placebo arm of the trial.

Also known as: control

Placebo

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologist's (ASA) physical classification I and II
• tonsillectomy or adenotonsillectomy
• admission to extended postoperative care unit

You may not qualify if:

• use of monoamine oxidase inhibitors, serotonin reuptake inhibitors or tricyclic antidepressants
• requirement of preoperative sedation
• recent dextromethorphan use (\<24 h before surgery)
• intolerance, sensitivity or contraindication to any agents used in the study
• pre-existing chronic pain or chronic analgesic use
• body mass index (BMI) for age percentile greater than 90
• confounding procedural factors which might affect the validity of the data
• inability to adhere to study protocol
• contraindication to volatile anesthetics

Sponsors & Collaborators

• Dr. Rachel Rooney: lead

Related Publications (9)

• Silverman DG, O'Connor TZ, Brull SJ. Integrated assessment of pain scores and rescue morphine use during studies of analgesic efficacy. Anesth Analg. 1993 Jul;77(1):168-70. No abstract available.

  PMID: 8317727 BACKGROUND

• Kawamata T, Omote K, Kawamata M, Namiki A. Premedication with oral dextromethorphan reduces postoperative pain after tonsillectomy. Anesth Analg. 1998 Mar;86(3):594-7. doi: 10.1097/00000539-199803000-00031.

  PMID: 9495423 BACKGROUND

• Dawson GS, Seidman P, Ramadan HH. Improved postoperative pain control in pediatric adenotonsillectomy with dextromethorphan. Laryngoscope. 2001 Jul;111(7):1223-6. doi: 10.1097/00005537-200107000-00015.

  PMID: 11568544 BACKGROUND

• 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.

  PMID: 25624387 BACKGROUND

• Hasan RA, Kartush JM, Thomas JD, Sigler DL. Oral dextromethorphan reduces perioperative analgesic administration in children undergoing tympanomastoid surgery. Otolaryngol Head Neck Surg. 2004 Nov;131(5):711-6. doi: 10.1016/j.otohns.2004.06.709.

  PMID: 15523452 BACKGROUND

• Rose JB, Cuy R, Cohen DE, Schreiner MS. Preoperative oral dextromethorphan does not reduce pain or analgesic consumption in children after adenotonsillectomy. Anesth Analg. 1999 Apr;88(4):749-53. doi: 10.1097/00000539-199904000-00012.

  PMID: 10195517 BACKGROUND

• Weinbroum AA, Rudick V, Paret G, Ben-Abraham R. The role of dextromethorphan in pain control. Can J Anaesth. 2000 Jun;47(6):585-96. doi: 10.1007/BF03018952.

  PMID: 10875724 BACKGROUND

• Brown KA, Laferriere A, Lakheeram I, Moss IR. Recurrent hypoxemia in children is associated with increased analgesic sensitivity to opiates. Anesthesiology. 2006 Oct;105(4):665-9. doi: 10.1097/00000542-200610000-00009.

  PMID: 17006062 BACKGROUND

• Steinberg GK, Bell TE, Yenari MA. Dose escalation safety and tolerance study of the N-methyl-D-aspartate antagonist dextromethorphan in neurosurgery patients. J Neurosurg. 1996 May;84(5):860-6. doi: 10.3171/jns.1996.84.5.0860.

  PMID: 8622162 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rachel Rooney, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Rachel Rooney

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: April 4, 2016
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share