A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy

NCT01267136 | Completed Phase 4 Results

• 1 other identifier: 1010-086
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. Tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. Seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population. Hypotheses H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen. H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.

Conditions

Tonsillitis; Pain

Keywords

Tonsillectomy; Pain; Pediatric; Opioids; Tramadol; Codeine

Outcome Measures

Primary Outcomes (1)

• Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.

  Average number of post-operative days with pain score \>4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).

  Efficacy was assessed daily during the 10-day postoperative recovery period.

Secondary Outcomes (1)

• Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.

  Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.

Study Arms (2)

Capital® with Codeine Suspension

EXPERIMENTAL

Drug: Codeine with acetaminophen

Tramadol suspension

ACTIVE COMPARATOR

Drug: Tramadol suspension

Interventions

Codeine with acetaminophen DRUG

Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)

Also known as: Capital® with Codeine Suspension, Acetaminophen and Codeine phosphate suspension

Capital® with Codeine Suspension

Tramadol suspension DRUG

Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).

Also known as: tramadol hydrochloride, Ultram

Tramadol suspension

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child must be scheduled to undergo tonsillectomy (with or without adenoidectomy).
• Child must be between the ages of 4 and 15 at the time of enrollment.
• Child and caregiver must be English-speaking.
• The same caregiver (e.g., mother) must agree to complete all study assessments with child to ensure consistency.

You may not qualify if:

• Child cannot self-assess pain due to conditions such as developmental delays, chromosomal abnormalities, and other syndromes.
• Child had significant adverse effects to codeine, tramadol, or acetaminophen in the past.
• Child has a known underlying seizure disorder (not febrile seizure).
• Child has known underlying renal or liver dysfunction (with creatinine, aspartate aminotransferase \[AST\]/amino alanine transferase \[ALT\], above normal value for age, respectively).
• Child or caregiver is not English-speaking.
• The same caregiver (e.g., mother) is unable to complete all follow-up assessments.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Tonsillitis; Pain

Interventions

Codeine; Acetaminophen; Economics; Tramadol

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Health Care Economics and Organizations; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Limitations and Caveats

There was insufficient power to detect differences in safety.

Results Point of Contact

• Title: Andrea Postier/Clinical Research Program Manager
• Organization: Children's Hospitals and Clinics of Minnesota

andrea.postier@childrensmn.org

612-813-6409

Study Officials

• Stefan J Friedrichsdorf, M.D.

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 28, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 17, 2014
• Results First Posted: April 17, 2014

Record last verified: 2014-03

Locations

US (1)