Clinical trial NCT03292068: Children Recovering From Tonsil Surgery
Official title: Children Recovering From Tonsil Surgery Following Day Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tonsillitis
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 576
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triangulation design will be used including both qualitative and quantitative methods. All the intervention groups will receive usual care in combination with a special intervention. The control group will only receive usual care. In the study the three interventions will be performed at one hospital each.
Primary purpose: TREATMENT

Brief summary: Children recovering from tonsil surgery following day surgery Tonsil surgery - self-care and treatment - the TONIST-study The main objective of this study is to evaluate the effect and experience of acupuncture, acupressure, specially designed diet and telephone counselling on children's surgery-related symptoms, quality of life and costs during recovery after tonsillectomy (TE) or tonsillotomy (TT).

Early discharge from hospitals means that patients have to deal with much of the post-operative care during recovery process on their own or with the help of relatives. The recovery period may be a progressive process of physical weakness (1,2).

In Sweden, 14 000 tonsil surgeries per year are performed, about 50% children under 15 years because of obstruction, of TE, tonsillectomy, and TT, tonsillomy. Children's tonsil surgery following day surgery are in focus for this study. Both qualitative and quantitative methods will be used.

Detailed description: The TONIST-study

Acronyms:

APU Acupuncture, APR Acupressure, CReDECI Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare, CG control group, IG intervention Group, PONV Postoperatively nausea and vomiting, PRiC Postoperative Recovery in Children, EQ5D EuroQol five dimensions' questionnaire

A pilot study will include evaluating the amount of issues in the instruments perceived possible to answer and/or the number of measurement points are reasonable.

Children's tonsil surgery following day surgery are in focus for this study. Children admitted for day surgery is monitored only a few hours after the surgery before going home when the parents must take the main responsibility for the care and monitoring during the recovery period (3). The present study design does not depend on the type of tonsil operation implemented, but the percentage advantage lodge will result in the description. Fifty percent of these surgical procedures are performed as day surgeries (4). The procedure causes a postoperative period of pain and risk of bleeding (5). The pain increases up to seven days after surgery, leading to problems with eating, drinking and sleeping (6). Children seem to receive too little analgesia and there seems to be a great need for postoperative information (7). Especially when the procedure is performed as day surgery the professional postoperative treatment at hospital is transferred to the patient to perform self-care. For the parents of young children, it could be a demanding task (8). Furthermore, the children's need of care could lead to loss of income since temporary parental benefit for care of the child will be necessary as well as absence from work and increased costs for the healthcare organization. Evidence-based interventions should constitute the basis for development of health care and post-operative interventions are often very complex, involving physical and emotional mechanisms. There is a gap in knowledge about effective interventions after tonsil surgery that could ease the self-care performed at home. In the proposed trials the investigators want to evaluate the effects of APU, APR, specially designed diet and extended telephone counselling on relieving common postoperative symptoms.

Qualitative and quantitative methods will be used. All the intervention groups will receive usual care in combination with a special intervention. The control group will receive usual care. The three interventions will be performed at one hospital each.

The investigators will apply "The new Medical Research Council Guidance" (9). Guidelines, CReDECI, will be used (10). In accordance with these criteria, reporting will be intersected in several publications; articles on the development, structured literature review and pilot testing, testing PRiC for children under 4 years and adolescents over 12 years, the evaluation of interventions and implementations.

Intervention I: Combinating APU and APR the investigators will evaluate the effect and safety as administered in clinical use which is a more holistic approach.

Intervention II: A specially designed diet including protein-enriched ice cream as snacks and "Timbalkost", specially designed diet, originally made for patients suffering of dysphagia will be used. "Timbalkost" will be given as lunch and dinner. Ice crème will be available as a snack, with lemon, vanilla and caramel flavor.

Intervention III: Extended telephone counseling. A nurse will contact the Child/youth, or the parents, by telephone on day 1, 3, 5 and 10 postoperatively, to provide support and information. The nurse will fill in a protocol on what topics the counseling was about at each call.

Usual care will be given to CG, and the IG. Usual care consists routines at the clinic, such as sedatives prior surgery, anesthesia during the operation and ondansetron and/or metoclopramide for PONV (11). For pain, paracetamol and NSAID is administered routinely postoperatively. Morphine is given intravenously in case of severe pain. Current standard care concerning diet is most often advice to eat and drink normally.

Participants Children, 2-19years of age who undergo TE or TT will be asked to participate.

Primary outcome is throat pain measured with the questionnaire PRiC, change is being assessed up to 21 days following surgery. The three interventions are to be evaluated with registration of postoperatively recovery.

The primary outcome will be measured by PRiC regarding existing pain in the throat (12). Regarding pain, the child could in the enquiry choose one of four options; During the last day/night (within the last 24 hours) Have I had a sore throat with the opportunity to grade the answer Not at all, A little, alternatively Much or Very much.

Estimates for the number of children who need to be included in the study is based on the distribution of responses to the question "sore throat" that is, a sore throat the last 24 hours from the questionnaire PRiC. The control group is assumed to respond to the same distribution as the children in Bramhagen et al (12) and the children in the intervention group is assumed to have a positive shift in the distribution of answers as shown below, where 1 = Not at all throat pain, 2 = Little hurt throat, 3=Very sore throat or 4 = Very much sore throat.

A positive shift in response to previous study results in Bramhagen (12) is assumed in the Intervention Group.

In order to statistically ensure a difference between the intervention and control based on the conditions above, you need 138 children in each of the four groups, a total of 828 children. The method used is the Mann Whitney U test with 80% power and 5% alpha.

Secondary outcomes; change is being assessed following the surgery. The secondary outcome is any change in nausea, vomiting and other parts of the questionnaire PRiC. Analyzes regarding costs will be carried out both in a social and a medical perspective. Outcome after different types of surgery may emerge. The economic effects will be evaluated between IG and CG and between the interventions. Children and parent's experiences after surgery will be monitored through qualitative interviews. An economic evaluation of the three interventions combined with parents' absence from work will be made (IG and CG). Quality of life, including health-related status will be measured using EQ5D (questionnaire for health) (13).

Data collection for registration of the children' recovery from their surgery the instruments Postoperative Recovery in Children instrument (PRiC) (12) will be used in each Cg and IG.

PRiC is based on data about the general recovery of postoperative symptoms such as pain in the throat, including information on the various physical and emotional symptoms. PRiC is measured on a four-point scale children's signs and symptoms during the last day/night in the last 24 hours, not at all, a little, a lot or very much. It is questioned, for example, "I felt as if I would vomit, I have had vomiting, I have had a sore throat or had blood in my mouth." It is also requested for the child "I have found it difficult to eat, I have found it difficult to play/be active or have I found it difficult to attend daycare/school. Finally, the questionnaire asks about" Right now I feel very good, fairly good, quite bad or very bad (12).

For measuring pain, nausea and anxiety at baseline i.e. before surgery, preoperately the Numerical rating scale (NRS) will be used, asking the nurse to document in the child's medical record. The Investigators will seek to gain access to the child's medical record. The instruments will be used collecting data according to the time schedule (Table 2) in both IG and CG and with help from the parents if needed. PRiC will be used on the day of surgery and thereafter assessed over time following the surgery daily on postoperative days 1-7 the postoperative days 10, 14, 21. EQ5D will be measures at baseline 14 Days Before surgery and thereafter assessed over time on postoperative days 10, 14 and 21. Diary for Specially designed diet will be assessed over time daily following surgery as long as the Child use the diet. Protocol and diary for telephone follow up will be assessed over time following surgery on postoperative days 1, 3, 5 and 10. Diary for APU and APR will be assessed over time following surgery on the surgery day and daily the postoperative days 1-10.

Measuring time points:

Numerical rating scale NRS (0-10) pain, nausea and anxiety measured before premedication on surgery day.

PRiC, recovery measured on surgery day, daily following surgery on days 1-7 and on days 10, 14, 21 following surgery.

EQ5D, Quality of life and health measured 14 days before surgery, postoperative days 10, 14 and 21 following surgery.

Diary for Specially designed diet Experience and number of meals measured up to 7 days after surgery.

Protocol and diary for telephone follow up. Documentation of given support and on the postoperative days 1, 3, 5 and up to day 10 postoperatively.

Protocol and diary for APU and APR Documentation of when APU and APR were used for any reason and when removed. Documentation daily on surgery day and postoperative days 1-10.

The diaries on needle stimulation and the food will be collected after one week, data on the telephone calls after 10 days in the IG:s. For each patient specific operation data will be collected on day one and postoperative complications after 30 days and 6 months, in the child´s medical records and in the Swedish Tonsil register.

The economic evaluations: EQ5D, data about patients' contacts with healthcare professionals and the parents' number of days they are absent from work. Data on indication for surgery, surgical techniques and hemostasis method will be collected from the children's medical record at baseline and any postoperative complications within 6 months.

Ten children (or parents if the child is younger than 15 years of age) in each IG and the CG will be interviewed using open questions at POD 14 (60 interviews in total) about their experiences of the respectively IG or CG.

The quantitative data will be analyzed using relevant statistical methods (Altman 2006). Depending on type of data and distribution either parametric (ANOVA) or non-parametric assays to assess group differences. For analysis of binary outcome measures the investigators will apply logistic regression models.

The interviews will be transcribed and analyzed using content analysis (14) with an inductive approach to illuminate children's/parents' experiences.

Eligibility criteria: Inclusion Criteria: Children, 2-19 years of age who undergo Tonsillectomy or Tonsillotomi be asked to participate.

Exclusion Criteria:

For children who have aversion, intolerance or allergy to ice cream or any of the ingredients in it the exclusion of the ice cream as a snack will be done.

Primary outcomes:
measure: Sore throat item, in the instrument Postoperative Recovery in Children instrument (PRiC), change assessed
timeFrame: On the surgery day, Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day
Secondary outcomes:
measure: Numerical Rating Scale, NRS (0-10) Nausea
timeFrame: Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2
measure: Postoperative Recovery in Children, PRiC, Questionaire.
timeFrame: Daily during the postoperative days 1-7 and during the 10:th, 14:th and the 21:th day
measure: EQ5D Economic effect between, assessment of change
timeFrame: On the 14:th day before surgery, Daily during the 10:th, 14:th and the 21:th postoperative days
measure: Protocol and diary for telephone follow up, assessment of change
timeFrame: On the first postoperative day and on the 3:rd, 5:th och 10:th day postoperatively.
measure: Diary for acupuncture and acupressure, assessment of change
timeFrame: On the surgery day and daily on the postoperative days 1 to at 10. Measurement to the high tenth day postoperatively depending on whether the child is using the APU and / or LFS for so long.
measure: Diary for specially designed diet including ice Cream, assessment of change
timeFrame: As long as meals are consumed, daily, up to 10 days following surgery day.
measure: Numerical Rating Scale, NRS (0-10) anxiety
timeFrame: Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2
measure: Numerical Rating Scale, NRS (0-10)
timeFrame: Baseline, before premedication before the surgey starts i.e. preoperative and on postopertive day 2
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Helena Rosén
Study officials:
affiliation: Health scienses, Faculty of medicine, Lund University
name: Helena i Rosén, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health scienses, Faculty of medicine, Lund University
name: Lena-karin Erlandsson, PhD
role: STUDY_DIRECTOR
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