Phase 3
Completed N=120
Pediatric Tonsillectomy Pain Reduction Study
Source: ClinicalTrials.gov NCT00678379 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Total Number of Post-operative Doses of Analgesics. — 12; 12; 14 number of doses
◆ Published Evidence
Emerging
13citations · ~1 / year
Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy.
Summary
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).
Linked Publications
-
Comparison of clonidine, local anesthetics, and placebo for pain reduction in pediatric tonsillectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Post-operative Doses of Analgesics. |
12; 12; 14 | — |
| SECONDARY Median Number of Pain Medication Doses |
3.0; 3; 3 | — |
| SECONDARY Total Time Until Discharge From Hospital. |
122; 111; 120 | — |
| SECONDARY Mean Visual Analog Scale Pain Number. |
3; 3; 3; 3; 4; 5 | — |
| SECONDARY Number and Percent of Participants Able to Tolerate Only Liquids |
16; 33; 30; 8; 13; 23 | — |
| SECONDARY Number and Percent of Participants Able to Tolerate Only a Soft Diet |
26; 22; 26; 18; 26; 18 | — |
| SECONDARY Number and Percent of Participants Able to Tolerate a Regular Diet |
7; 4; 1; 18; 8; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Age 3 - 17 years old
- BMI < 35
- Negative pregnancy test in female patients age 10 and older
- Diagnosed with adenotonsillar hypertrophy, recurrent adenotonsillitis or upper airway obstruction and will be undergoing tonsillectomy alone or adenotonsillectomy
Exclusion Criteria
- Diagnosis of obstructive sleep apnea
- Patient with peritonsillar abscess
- Allergy to study medication
- Any major systemic illness, genetic disorder or diagnosed syndrome
- Bleeding disorder
Data sourced from ClinicalTrials.gov (NCT00678379) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.