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

NCT ID: NCT02727491

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-09-30

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.

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dextromethorphan

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

Group Type: EXPERIMENTAL

Dextromethorphan

Intervention Type: 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).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

dextromethorphan hydrobromide; control

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Rachel Rooney

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rachel Rooney

Dr. Rachel Rooney

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rachel Rooney, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

References

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.

Reference Type: BACKGROUND

PMID: 8317727 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9495423 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25624387 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 10195517 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10875724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17006062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8622162 (View on PubMed)

Other Identifiers

ANAE-182-10

Identifier Type: -

Identifier Source: org_study_id