Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain

NCT01672112 | Completed Phase 4 DMC

• 1 other identifier: 2011/02076
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of codeine is dependent on its demethylation to morphine. This extent of demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors. Codeine has been the mainstay of analgesia for patients after craniotomy for many years. Traditionally, craniotomies were not thought to be very painful procedures, hence the use of codeine, a moderately potent opioid (when compared to morphine). However, in recent years, it has been found that up to 70% of post-craniotomy patients have moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and patients on these stronger opioids generally had lower pain scores and better satisfaction. No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral codeine. Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain relief in post-craniotomy patients.

Conditions

Postcraniotomy Pain

Keywords

analgesic efficacy; oral codeine; oral oxycodone; postcraniotomy

Outcome Measures

Primary Outcomes (1)

• To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.

  24hr post-op.

Secondary Outcomes (1)

• To look at the incidence of adverse events in the oxycodone and codeine groups.

  Up to 72hrs post-op.

Study Arms (2)

Codeine

OTHER

Oral Codeine 60mg 6hrly/prn

Drug: Codeine

Oxycodone

ACTIVE COMPARATOR

Oral Oxycodone 5mg 6hrly/prn

Drug: Oxycodone

Interventions

Oxycodone DRUG

Oral Oxycodone 5mg 6hrly/prn

Also known as: Oxynorm Immediate Release

Oxycodone

Codeine DRUG

Oral Codeine 60mg 6hrly/prn

Also known as: Codeine Phosphate

Codeine

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 21-70 years of age
• Planned elective craniotomy
• ASA 1-3
• GCS 15 pre and post-op
• Able to understand and use the visual analogue scale

You may not qualify if:

• Patients with GCS \< 15 pre and/or post-op.
• Patients who are unable to quantify pain according to VAS scale.
• Patients who will be left intubated post-op.
• Contraindications and/or allergies to any of the trial drugs.
• Patients with renal and/or hepatic impairment.
• Patients with decreased respiratory reserves.
• Patients with post-op cognitive dysfunction.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

Location

MeSH Terms

Interventions

Oxycodone; Codeine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; 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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

SG (1)