Results of a double-blinded, randomized, controlled trial indicate that
when children diagnosed with sleep apnea must have their tonsils
removed, Coblation-assisted intracapsular technique results in less
post-operative pain and a quicker return to normal eating and activity
than electrocautery. Interestingly, older children who had
Coblation-assisted tonsillectomy exhibited the most dramatic reduction
in pain.
Tonsillectomy remains one of the most common childhood surgeries with an increasing number of the surgeries being done to treat obstructive sleep apnea or sleep disordered breathing. In children, untreated obstructive sleep apnea and sleep disordered breathing can result in failure to thrive and behavior and learning problems.
Coblation is a non-heat driven process in which radiofrequency energy is applied to a conductive medium (usually saline) causing a highly focused plasma field to form around the electrodes. The plasma field is comprised of highly ionized particles. These ionized particles have sufficient energy to break organic molecular bonds within tissue. Instead of exploding tissue, Coblation causes a low temperature molecular disintegration, resulting in minimal tissue damage to surrounding areas.
Use of Coblation technology for tonsillectomy has grown in the last several years. A new study, undertaken by a single surgeon at one surgical location, asks the question of how Coblation-assisted intracapsular tonsillectomy compares to the traditional method of removing tonsils by electrocautery. The results of the study "Randomized controlled trial of Coblation versus electrocautery tonsillectomy," will be presented by author Kay Chang, MD, of the Department of Otolaryngology-Head and Neck Surgery at Standford University School of Medicine at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO EXPO, being held September 19-22, 2004, at the Jacob K. Javits Convention Center, New York City, NY.
Methodology: This study included 101 children scheduled to have tonsillectomy and adenoidectomy for obstructive sleep apnea or sleep disordered breathing. Patients with significant comorbidities or significant history of recurrent/chronic tonsillitis were excluded. Patients were randomized into two study groups; coblation-assisted intracapsular tonsillectomy and electrocautery tonsillectomy.
The coblation-assisted intracapsular tonsillectomy was performed from the surface inward without penetrating the capsule with the wand set at the Coblate 9 setting. Electrocautery tonsillectomy was performed using traditional subcapsular tonsil dissection with the Bovie set at 20 watts. Adenoidectomy in both groups was performed using adenoid curette and hemostasis achieved with suction electrocautery. Anesthesia and recovery room protocols were standardized for all patients.
All patients were seen by the pediatric otolaryngology nurse practitioner on either day one or two and the following measures were collected by questionnaire: (1) both the child and parental perception of pain as graded using the Wong-Baker FACES pain rating scale, (2) type and frequency of pain medication, (3) presence of nausea and/or vomiting, (4) percent of normal diet that patient is eating, (5) percent of normal activity level that patient is demonstrating, (6) whether or not parent missed work, (7) complications or re-admissions. The parents were given the same questionnaire by phone at two additional timepoints, days three or four and days five and six.
All statistical analyses were performed using StatView 5.0 software for Macintosh. Continuous data are displayed as mean � SD. Comparisons between means were performed using Student's unpaired two-tail t-test for equal or unequal variances, as appropriate. Statistical significance was accepted for P values less than .05.
Results: Fifty two children (56 percent male; 44 percent female) with a mean age of 6.4 � 3.5 received Coblation tonsillectomy and 49 children (49 percent male; 51 percent female) with a mean age of 6.2 � 3.4 received electrocautery tonsillectomy. Mean weight was 28.5 � 19.1 kg and 30.2 � 23.2 kg, respectively.
Operative time was similar between the two groups, with no statistically significant difference. Adenoidectomy was performed in all patients except one. Surgeries performed in conjunction with Coblation tonsillectomy included 15 bilateral tympanostomy tubes, one nasal endoscopy with cauterization, and one direct laryngoscopy. Surgeries performed in conjunction with electrocautery tonsillectomy included 17 bilateral tympanostomy tubes, two maxillary sinus lavages, one frenuloplasty, and one excision of tongue mucocele.
Estimated blood loss was also similar between the two groups; almost all occurred during adenoidectomy. There were no complications in either group and one re-admission in the electrocautery group for dehydration. Rates of planned admissions and nausea were similar.
The differences in pain assessment were statistically significant to p<0.005 in every comparison. Up to 29 percent of electrocautery patients had only mild pain (score from 0-3), but did not improve over the next five days. Forty percent of Coblation patients had mild pain at days 1-2, by days 5-6, increased to 69 percent. The proportion of patients reporting severe pain (score from 8-10) was significantly lower in Coblation versus electrocautery. Analgesic use was similar between the two groups, but on days 5-6, there was a statistically significant decrease in Tylenol use for the Coblation group. By days 5-6, 75 percent of Coblation patients were eating near normal, compared to only 27 percent of electrocautery patients. Activity levels mirrored the oral intake findings.
Children older than nine receiving electrocautery tended to have the most pain. Pain scores were similar in the older and younger children receiving Coblation, but were worse in the older children receiving electrocautery. Fewer parents missed work in the Coblation group compared to the electrocautery group, however this was not statistically significant.
Conclusion: This prospective, randomized, double-blinded controlled study demonstrates distinct advantages in postoperative recovery for intracapsular Coblation tonsillectomy compared to traditional subcapsular electrocautery tonsillectomy. It confirms previous research that Coblation tonsillectomy results in less post-operative pain (particularly for older children) and quicker return to normal eating and activity levels.
Tonsillectomy remains one of the most common childhood surgeries with an increasing number of the surgeries being done to treat obstructive sleep apnea or sleep disordered breathing. In children, untreated obstructive sleep apnea and sleep disordered breathing can result in failure to thrive and behavior and learning problems.
Coblation is a non-heat driven process in which radiofrequency energy is applied to a conductive medium (usually saline) causing a highly focused plasma field to form around the electrodes. The plasma field is comprised of highly ionized particles. These ionized particles have sufficient energy to break organic molecular bonds within tissue. Instead of exploding tissue, Coblation causes a low temperature molecular disintegration, resulting in minimal tissue damage to surrounding areas.
Use of Coblation technology for tonsillectomy has grown in the last several years. A new study, undertaken by a single surgeon at one surgical location, asks the question of how Coblation-assisted intracapsular tonsillectomy compares to the traditional method of removing tonsils by electrocautery. The results of the study "Randomized controlled trial of Coblation versus electrocautery tonsillectomy," will be presented by author Kay Chang, MD, of the Department of Otolaryngology-Head and Neck Surgery at Standford University School of Medicine at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO EXPO, being held September 19-22, 2004, at the Jacob K. Javits Convention Center, New York City, NY.
Methodology: This study included 101 children scheduled to have tonsillectomy and adenoidectomy for obstructive sleep apnea or sleep disordered breathing. Patients with significant comorbidities or significant history of recurrent/chronic tonsillitis were excluded. Patients were randomized into two study groups; coblation-assisted intracapsular tonsillectomy and electrocautery tonsillectomy.
The coblation-assisted intracapsular tonsillectomy was performed from the surface inward without penetrating the capsule with the wand set at the Coblate 9 setting. Electrocautery tonsillectomy was performed using traditional subcapsular tonsil dissection with the Bovie set at 20 watts. Adenoidectomy in both groups was performed using adenoid curette and hemostasis achieved with suction electrocautery. Anesthesia and recovery room protocols were standardized for all patients.
All patients were seen by the pediatric otolaryngology nurse practitioner on either day one or two and the following measures were collected by questionnaire: (1) both the child and parental perception of pain as graded using the Wong-Baker FACES pain rating scale, (2) type and frequency of pain medication, (3) presence of nausea and/or vomiting, (4) percent of normal diet that patient is eating, (5) percent of normal activity level that patient is demonstrating, (6) whether or not parent missed work, (7) complications or re-admissions. The parents were given the same questionnaire by phone at two additional timepoints, days three or four and days five and six.
All statistical analyses were performed using StatView 5.0 software for Macintosh. Continuous data are displayed as mean � SD. Comparisons between means were performed using Student's unpaired two-tail t-test for equal or unequal variances, as appropriate. Statistical significance was accepted for P values less than .05.
Results: Fifty two children (56 percent male; 44 percent female) with a mean age of 6.4 � 3.5 received Coblation tonsillectomy and 49 children (49 percent male; 51 percent female) with a mean age of 6.2 � 3.4 received electrocautery tonsillectomy. Mean weight was 28.5 � 19.1 kg and 30.2 � 23.2 kg, respectively.
Operative time was similar between the two groups, with no statistically significant difference. Adenoidectomy was performed in all patients except one. Surgeries performed in conjunction with Coblation tonsillectomy included 15 bilateral tympanostomy tubes, one nasal endoscopy with cauterization, and one direct laryngoscopy. Surgeries performed in conjunction with electrocautery tonsillectomy included 17 bilateral tympanostomy tubes, two maxillary sinus lavages, one frenuloplasty, and one excision of tongue mucocele.
Estimated blood loss was also similar between the two groups; almost all occurred during adenoidectomy. There were no complications in either group and one re-admission in the electrocautery group for dehydration. Rates of planned admissions and nausea were similar.
The differences in pain assessment were statistically significant to p<0.005 in every comparison. Up to 29 percent of electrocautery patients had only mild pain (score from 0-3), but did not improve over the next five days. Forty percent of Coblation patients had mild pain at days 1-2, by days 5-6, increased to 69 percent. The proportion of patients reporting severe pain (score from 8-10) was significantly lower in Coblation versus electrocautery. Analgesic use was similar between the two groups, but on days 5-6, there was a statistically significant decrease in Tylenol use for the Coblation group. By days 5-6, 75 percent of Coblation patients were eating near normal, compared to only 27 percent of electrocautery patients. Activity levels mirrored the oral intake findings.
Children older than nine receiving electrocautery tended to have the most pain. Pain scores were similar in the older and younger children receiving Coblation, but were worse in the older children receiving electrocautery. Fewer parents missed work in the Coblation group compared to the electrocautery group, however this was not statistically significant.
Conclusion: This prospective, randomized, double-blinded controlled study demonstrates distinct advantages in postoperative recovery for intracapsular Coblation tonsillectomy compared to traditional subcapsular electrocautery tonsillectomy. It confirms previous research that Coblation tonsillectomy results in less post-operative pain (particularly for older children) and quicker return to normal eating and activity levels.
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