A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Condition: Tonsillitis; Pain
MeSH terms: Tonsillitis
Intervention: Codeine with acetaminophen; Tramadol suspension
Intervention description: 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); 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).
Intervention MeSH terms: Acetaminophen; Tramadol; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 4 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Tonsillectomy; Pain; Pediatric; Opioids; Tramadol; Codeine

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.