Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01568372|
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Telephone follow-up||Not Applicable|
Tonsillectomy in children is a common elective day surgery. In the United States, 530 000 children under 15 years of age underwent a tonsillectomy in 2006. This minor surgery generates moderate to severe pain and many postoperative complications, both in the early postoperative phase and for at least 7 days. Patients are discharged home a few hours after tonsillectomy, and parents take over their child's care. But not all parents have the ability and knowledge required to adequately manage the pain and complications. This sub-optimal care situation has a significant impact on the child's convalescence and can lead to poor pain management, dehydration, poor rest and sleep quality, nausea, vomiting as well as an increase in the risk of secondary haemorrhage. Many interventions have been evaluated to improve pain management, such as education strategies for parents or children and tools to guide parents. However, none of these strategies have obtained significant results on children's pain intensity post-tonsillectomy.
A nurse telephone follow-up can significantly reduce pain intensity of adults who undergo ambulatory surgery. This intervention is defined as multiple telephone calls made to the patient by a nurse, after discharge, to provide information, and review discharge prescriptions and management of care by the patient himself or by a care-giver. Only a few studies have explored nurse telephone follow-up for children who underwent tonsillectomy. The design of these studies, including the time-periods chosen for data collection, were not properly determined to adequately evaluate the impact of the intervention on management of pain and prevention of postoperative complications. Thus, we planned to determine if a nurse telephone follow-up, made to parents following their child's tonsillectomy, would contribute to decrease pain intensity, incidence of postoperative complications and resort to other healthcare services.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of a Nurse Telephone Follow-up on Post-tonsillectomy Pain Management and Complications in Children: A Randomized Clinical Trial|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Nurse telephone follow-up
This group received a telephone follow-up by a nurse following discharge from the hospital and up until the 10th postoperative day, which is considered as the usual period of healing for a tonsillectomy
Other: Telephone follow-up
The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
No Intervention: Standard care group
This group received the standard care which consisted of an informative session before discharge and no follow-up once discharged home.
- Pain intensity scores on the 3rd day after surgery [ Time Frame: Pain assessed on the 3rd postoperative day ]Mean pain intensity score on the 3rd postoperative day (POD)
- Pain intensity scores on the 5th day after surgery [ Time Frame: Pain assessed on the 5th postoperative day ]Mean pain intensity score on the 5th postoperative day (POD)
- Pain intensity scores on the 10th day after surgery [ Time Frame: Pain assessed on the 10th postoperative day ]Mean pain intensity score on the 10th postoperative day (POD)
- postoperative complications [ Time Frame: Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day ]Assess complications and adverse events at each time points of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568372
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Sylvie Le May, PhD||Université de Montréal|