ChildrenNCT01389349
Acupuncture for Tonsillectomy Pain
A study testing Acupuncture in people with Children and Postoperative Pain, run by Children's ENT of San Diego, Inc. at 2 sites in United States.
Trial summary
Pain after tonsillectomy can be severe and last ten days. Various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Children, Postoperative Pain, Tonsillar Hypertrophy
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s)
Who cannot join
- Developmental Delay
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Specialty Clinic
El Centro, California, 92243
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
Pain after tonsillectomy can be severe and last ten days.
Various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. Patients are discharged to home usually on the day of surgery and often suffer significant pain and nausea. Pain medication is often prescribed which can cause nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may require intravenous hydration at an emergency department.
Read more
"Battlefield acupuncture " has been recently developed by the US Air Force and is now being used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma. This protocol consists of five acupuncture points on the outer ear.
A recent study has demonstrated decreased pain and agitation in children undergoing ear tube insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are able to attend school the next day.
The investigators have been encouraged by the benefits of acupuncture during surgery for ear tube patients and also wounded warriors recovering from their injuries. These findings motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and nausea.
- Conditions
- Children, Postoperative Pain, Tonsillar Hypertrophy, Obstructive Sleep Apnea, Chronic Tonsillitis
- Being tested
- Acupuncture, Sham Control
- Keywords
- tonsillectomy, adenotonsillectomy, acupuncture, children, postoperative pain, postoperative nausea
- Medical subject headings
- Pain, Postoperative, Sleep Apnea, Obstructive, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Battlefield acupuncture protocol
Sham ControlOther
Sham control acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Other: Acupuncture |
| Sham Control | Sham comparator | Not described Receives: Other: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Response
Families will be contacted via telephone by a member of the study team other than Dr. Ochi on postoperative days 1 and 6. During these follow-up phone calls a member of the study team will review the daily diary with the parent and also inquire about oral intake, activity level, complications and any additional medical encounters.
Measured: Postoperative days 1 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's ENT of San Diego, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Responsible party
- Principal investigator, James W Ochi, M.D., Children's ENT of San Diego, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389349
- Sponsor's protocol ID
- 2322
- Status last verified
- May 2012
- First submitted
- 6 Jul 2011
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Tonsillectomy Pain
- ClinicalTrials.gov ID
- NCT01389349
- Acronym / sponsor ID
- 2322
- Conditions
- Children, Postoperative Pain, Tonsillar Hypertrophy, Obstructive Sleep Apnea, Chronic Tonsillitis
- Keywords
- tonsillectomy, adenotonsillectomy, acupuncture, children, postoperative pain, postoperative nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Children's ENT of San Diego, Inc.University, hospital or other
- Collaborators
- Rady Children's Hospital, San Diego
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain after tonsillectomy can be severe and last ten days.
Various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. Patients are discharged to home usually on the day of surgery and often suffer significant pain and nausea. Pain medication is often prescribed which can cause nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may require intravenous hydration at an emergency department.
"Battlefield acupuncture " has been recently developed by the US Air Force and is now being used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma. This protocol consists of five acupuncture points on the outer ear.
A recent study has demonstrated decreased pain and agitation in children undergoing ear tube insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are able to attend school the next day.
The investigators have been encouraged by the benefits of acupuncture during surgery for ear tube patients and also wounded warriors recovering from their injuries. These findings motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and nausea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: Acupuncture |
| Sham Control | Sham comparator | Other: Sham Control |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s)
Key exclusion criteria (1 listed)
- Developmental Delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureBattlefield acupuncture protocol | Other | Acupuncture |
| Sham ControlSham control acupuncture | Other | Sham Control |
Primary outcome
Pain Response
Time frame: Postoperative days 1 and 6
Families will be contacted via telephone by a member of the study team other than Dr. Ochi on postoperative days 1 and 6. During these follow-up phone calls a member of the study team will review the daily diary with the parent and also inquire about oral intake, activity level, complications and any additional medical encounters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
Related trials for Children
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Children and Postoperative Pain, run by Children's ENT of San Diego, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Response (time frame: Postoperative days 1 and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.