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

September 17, 2020 updated by: Dr. Rachel Rooney

A Prospective Randomized Double-blind Placebo Controlled Trial; Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With Institutional ethics board and Health Canada approval and parental consent and child assent, 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. Pain scores were collected preoperatively at rest and then at 1,2,3,8,9,10 and 24 hours postoperatively using the validated Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). Secondary outcomes include nausea, vomiting, respiratory depression, and bleeding recorded by blinded observers 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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dextromethorphan
1 mg/kg of dextromethorphan syrup orally 30 min preoperatively and then again 8 hours post-tonsillectomy
Drug: Dextromethorphan
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).
Other Names:
  • dextromethorphan hydrobromide
Placebo Comparator: Placebo
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
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.
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
integrated assessment of pain scores and opioid use
Time Frame: 24 hours postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid-related adverse effects
Time Frame: up to 24 hours postoperatively
nausea, vomiting, respiratory depression, bleeding
up to 24 hours postoperatively
pain scores
Time Frame: 1,2,3,8,9 and 10 hours postoperatively
Pain scores at rest on the CHEOPS pain scale
1,2,3,8,9 and 10 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Rachel Rooney

Investigators

  • Principal Investigator: Rachel Rooney, MD, FRCPC, Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANAE-182-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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