Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children
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| First Received Date ICMJE | March 26, 2012 | ||||
| Last Updated Date | March 30, 2012 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01568372 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
postoperative complications [ Time Frame: Complications assessed on the following postoperative days: First day, 3rd day, 5th day and 10th day ] [ Designated as safety issue: Yes ] Assess complications and adverse events at each time points of the study |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children | ||||
| Official Title ICMJE | Efficacy of a Nurse Telephone Follow-up on Post-tonsillectomy Pain Management and Complications in Children: A Randomized Clinical Trial | ||||
| Brief Summary | The purpose of this study is to determine if a nurse telephone follow-up to parents of children who underwent a removal of their tonsils would be effective in reducing pain intensity, complications and resort to other healthcare services |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Other: Telephone follow-up
The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 52 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 4 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01568372 | ||||
| Other Study ID Numbers ICMJE | Tonsils | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Julie Paquette, St. Justine's Hospital | ||||
| Study Sponsor ICMJE | St. Justine's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | St. Justine's Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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