Post-operative Pain Control After Pediatric Adenotonsillectomy
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Insomnia Sleep Studies, Other Indications, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 4 - 17 |
| Updated: | 4/27/2018 |
| Start Date: | November 2014 |
| End Date: | November 30, 2016 |
Comparing Narcotics With Non-steroidal Anti-inflammatory Drugs (NSAIDS) Post-operatively in Pediatric Patients Undergoing Adenotonsillectomy
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric
population in the United States. It is generally a well-tolerated procedure with
post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following
adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or
re-admission to the hospital. Post-operative analgesia is most commonly managed with
narcotic-containing pain medication. In recent years however, there is evidence that some
patients may manifest increased sensitivity to narcotics, resulting in life-threatening
respiratory compromise. Though there is a theoretical risk that nonsteroidal
anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,
evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains
inconclusive for these generally well-tolerated medications. The goal of this study is to
determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in
the management of post-operative pain following pediatric adenotonsillectomy, versus more
commonly used narcotic pain medication. The study design will be an initial retrospective
study to collect pilot data on the incidence of postoperative hemorrhage and indicators of
adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This
will be followed by a prospective, randomized, single-blind controlled study in which
orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone
(control intervention) in the postoperative period following adenotonsillectomy.
population in the United States. It is generally a well-tolerated procedure with
post-operative bleeding risk ranging from 3-5% in children. Post-operative pain following
adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or
re-admission to the hospital. Post-operative analgesia is most commonly managed with
narcotic-containing pain medication. In recent years however, there is evidence that some
patients may manifest increased sensitivity to narcotics, resulting in life-threatening
respiratory compromise. Though there is a theoretical risk that nonsteroidal
anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation,
evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains
inconclusive for these generally well-tolerated medications. The goal of this study is to
determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in
the management of post-operative pain following pediatric adenotonsillectomy, versus more
commonly used narcotic pain medication. The study design will be an initial retrospective
study to collect pilot data on the incidence of postoperative hemorrhage and indicators of
adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This
will be followed by a prospective, randomized, single-blind controlled study in which
orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone
(control intervention) in the postoperative period following adenotonsillectomy.
Post-operative pain management in pediatric patients undergoing adenotonsillectomy is
challenging not only for the child, but also for the clinician and caregiver. Uncontrolled
pain carries a high level of morbidity and can result in prolonged hospital stay and/or
readmission, dehydration, weight loss, and other undesirable effects. In light of recent
high-profile controversies regarding the safety of codeine the search for effective and safe
analgesia continues. The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS)
guidelines suggest that NSAIDs are safe to use in the post-operative period. Here, the
investigators compare bleeding risk and pain control using acetominophen-hydrocodone
(control) versus ibuprofen (intervention) in the post-operative period in pediatric patients
undergoing adenotonsillectomy. The investigators hypothesize that ibuprofen will not be
associated with increased bleeding risk and will control post-operative pain as well as
acetominophen-hydrocodone.
Initial retrospective chart review (Data to be extracted from the patients' charts):
- Demographic data
- Surgical data
- Postoperative data
- Descriptive analysis to determine incidence of postoperative bleeding following
adenotonsillectomy and its relation to demographic factors or surgical factors,
incidence of postoperative pain problems and relation to demographic or surgical
factors.
Prospective, randomized, single-blind trial:
- Study Group Allocation/Randomization: Study participants will be randomized into two
post-operative pain medication treatment arms, using block randomization. Patients who
are randomized into the test intervention arm will receive ibuprofen (10mg/kg/day every
6-8 hours) after surgery. Patients who are randomized into the control intervention will
receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours). This randomization
will be performed by Ansley Roche MD, a co-investigator. The operating surgeons will be
unaware of the group assignments at the time of randomization, at the time of surgery,
and in the post-operative period. (The participant and caregiver will not be blinded to
the type of post-operative pain medication they will receive.) Once a study participant
has been randomized to group, the group assignment information will be provided to the
otolaryngology resident at Egleston. The resident will write the appropriate
prescription and provide this to the patient's family prior to discharge.
- Postoperative pain assessment: Using the Faces Pain Scale , the pediatric patient will
indicate his/her pain level at scheduled intervals. Pain level will be recorded by the
caregiver and pain medication will be administered appropriately based on level of
patient's self-reported pain. A log of pain medication administered will be kept for
each dose given. The total amount of pain medication administered per kg per day will be
calculated by the study staff upon completion of the pain medication logs. Prior to
surgery, a member of the study team will conduct a brief standard training session for
parents to teach them how to correctly complete the medication log.
- Breakthrough pain: Patients who are randomized into the test intervention arm will
receive ibuprofen (10mg/kg/day every 6-8 hours) after surgery. Patients who are
randomized into the control intervention will receive hydrocodone-acetaminophen
(0.15mg/kg/day every 4-6 hours). Both post-operative intervention groups in this study
will have surgery for the same preoperative indications (adenotonsillitis or sleep
disordered breathing). If patients experience pain that is not controlled with the
specified intervention group medication, there will be a protocol in place for
breakthrough pain, as indicated below. Surgeons will be blinded to the intervention arm.
For patients who have pain that is not controlled by the randomized intervention, a
breakthrough pain protocol will be enacted. The protocol is as follows:
- Test intervention arm
1. Give hydrocodone-acetaminophen (0.15mg/kg/day hydrocodone) for pain score ≥6 no
more than ever 6 hours. If uncontrolled pain, see next bullet point.
2. Increase hydrocodone-acetaminophen dose to 0.2mg/kg/day hydrocodone per dose.
- Control intervention arm
1. Increase dose of hydrocodone-acetaminophen to 0.2 mg/kg/day hydrocodone For pain
score ≥ 6. If uncontrolled pain, see next bullet point.
2. Ibuprofen 10mg/kg/day no more than every 6 hours. If uncontrolled pain, see next
bullet point.
3. Acetaminophen 10mg/kg/day every 6 hours as needed.
Implementation of the breakthrough pain protocol will be documented. In order to maintain
surgeon blinding throughout the study, patient phone calls will be routed to the chief
resident on call who will follow the above breakthrough pain protocol.
A study staff member, excluding the surgeon, will contact parents/caretakers on
post-operative day 3 and post-operative day 7 to assist with medication log completion and
answer medical questions.
challenging not only for the child, but also for the clinician and caregiver. Uncontrolled
pain carries a high level of morbidity and can result in prolonged hospital stay and/or
readmission, dehydration, weight loss, and other undesirable effects. In light of recent
high-profile controversies regarding the safety of codeine the search for effective and safe
analgesia continues. The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS)
guidelines suggest that NSAIDs are safe to use in the post-operative period. Here, the
investigators compare bleeding risk and pain control using acetominophen-hydrocodone
(control) versus ibuprofen (intervention) in the post-operative period in pediatric patients
undergoing adenotonsillectomy. The investigators hypothesize that ibuprofen will not be
associated with increased bleeding risk and will control post-operative pain as well as
acetominophen-hydrocodone.
Initial retrospective chart review (Data to be extracted from the patients' charts):
- Demographic data
- Surgical data
- Postoperative data
- Descriptive analysis to determine incidence of postoperative bleeding following
adenotonsillectomy and its relation to demographic factors or surgical factors,
incidence of postoperative pain problems and relation to demographic or surgical
factors.
Prospective, randomized, single-blind trial:
- Study Group Allocation/Randomization: Study participants will be randomized into two
post-operative pain medication treatment arms, using block randomization. Patients who
are randomized into the test intervention arm will receive ibuprofen (10mg/kg/day every
6-8 hours) after surgery. Patients who are randomized into the control intervention will
receive hydrocodone-acetaminophen (0.15mg/kg/day every 4-6 hours). This randomization
will be performed by Ansley Roche MD, a co-investigator. The operating surgeons will be
unaware of the group assignments at the time of randomization, at the time of surgery,
and in the post-operative period. (The participant and caregiver will not be blinded to
the type of post-operative pain medication they will receive.) Once a study participant
has been randomized to group, the group assignment information will be provided to the
otolaryngology resident at Egleston. The resident will write the appropriate
prescription and provide this to the patient's family prior to discharge.
- Postoperative pain assessment: Using the Faces Pain Scale , the pediatric patient will
indicate his/her pain level at scheduled intervals. Pain level will be recorded by the
caregiver and pain medication will be administered appropriately based on level of
patient's self-reported pain. A log of pain medication administered will be kept for
each dose given. The total amount of pain medication administered per kg per day will be
calculated by the study staff upon completion of the pain medication logs. Prior to
surgery, a member of the study team will conduct a brief standard training session for
parents to teach them how to correctly complete the medication log.
- Breakthrough pain: Patients who are randomized into the test intervention arm will
receive ibuprofen (10mg/kg/day every 6-8 hours) after surgery. Patients who are
randomized into the control intervention will receive hydrocodone-acetaminophen
(0.15mg/kg/day every 4-6 hours). Both post-operative intervention groups in this study
will have surgery for the same preoperative indications (adenotonsillitis or sleep
disordered breathing). If patients experience pain that is not controlled with the
specified intervention group medication, there will be a protocol in place for
breakthrough pain, as indicated below. Surgeons will be blinded to the intervention arm.
For patients who have pain that is not controlled by the randomized intervention, a
breakthrough pain protocol will be enacted. The protocol is as follows:
- Test intervention arm
1. Give hydrocodone-acetaminophen (0.15mg/kg/day hydrocodone) for pain score ≥6 no
more than ever 6 hours. If uncontrolled pain, see next bullet point.
2. Increase hydrocodone-acetaminophen dose to 0.2mg/kg/day hydrocodone per dose.
- Control intervention arm
1. Increase dose of hydrocodone-acetaminophen to 0.2 mg/kg/day hydrocodone For pain
score ≥ 6. If uncontrolled pain, see next bullet point.
2. Ibuprofen 10mg/kg/day no more than every 6 hours. If uncontrolled pain, see next
bullet point.
3. Acetaminophen 10mg/kg/day every 6 hours as needed.
Implementation of the breakthrough pain protocol will be documented. In order to maintain
surgeon blinding throughout the study, patient phone calls will be routed to the chief
resident on call who will follow the above breakthrough pain protocol.
A study staff member, excluding the surgeon, will contact parents/caretakers on
post-operative day 3 and post-operative day 7 to assist with medication log completion and
answer medical questions.
Inclusion Criteria:
- ≥4 and ≤17 years old
- Meeting criteria for tonsillectomy based on AAO-HNS clinical guidelines:
Adenotonsillectomy is indicated for patients with recurrent adenotonsillitis and sleep
disordered breathing. Both groups in this study will have surgery for the same
preoperative indications
Exclusion Criteria:
- <4 or >17 years old
- Known bleeding diathesis (or family history of bleeding diathesis)
- Known allergy to any study medication
- participant/caregiver inability to understand or complete the required study
documentation (pain scales, medication logs)
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