A Phase 2 interventional study of Acetaminophen (paracetamol) and Normal Saline Flush in Adenotonsillitis and Tonsillitis, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 2 Years to 9 Years. Per ClinicalTrials.gov, last updated 2017-04-06.
Sponsored by Nationwide Children's Hospital · Phase 2, Interventional, and Treatment
Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses.
Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011).
To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
Once enrolled, subjects will have a standardized anesthetic on the day of surgery:
Following surgery and extubation, baseline vitals will be obtained and pain scores will be assessed in the post anesthesia care unit (PACU) via Faces, Legs, Activity, Cry, Consolability Scale (FLACC).The presence of emergence delirium will be assessed via Pediatric Agitation and Emergence Delirium scale (PAED). Those subjects whose pain score is assessed at \< 4 will receive standard postoperative care and no analgesics. Assessed pain scores > 4 will receive 0.5mcg/kg fentanyl q10 minutes as needed. Variables such as time to extubation in the PACU, time to first analgesic delivery, pain scores, # times/total dose of opioids given, presence of sedation, nausea/vomiting, duration of oxygen requirement in PACU, whether or not patient was discharged to floor on oxygen and total PACU time will be recorded during the duration of the patient's PACU stay. Subjects will be discharged to the inpatient floor from the PACU once standard discharge criteria have been met.
Following discharge from the PACU, standardized analgesics will be given for breakthrough pain (oral oxycodone 0.1mg/kg q4hrs pro re nata (PRN) pain). Enrolled patients will be followed during the duration of their inpatient stay. Duration of oxygen requirement on the floor, pain scores and number of administered oxycodone doses on the floor will be monitored and recorded.
102 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 250 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..
Drug: Acetaminophen (paracetamol) · Drug: Midazolam · Drug: Sevoflurane · Drug: Nitrous Oxide/Oxygen · Drug: Propofol · Drug: Morphine · Drug: Ondansetron · Drug: Dexamethasone
For this arm Morphine will be administered to manage pain.
Drug: Normal Saline Flush · Drug: Midazolam · Drug: Sevoflurane · Drug: Nitrous Oxide/Oxygen · Drug: Propofol · Drug: Morphine · Drug: Ondansetron · Drug: Dexamethasone
Acetaminophen IV (15 mg/kg).
Saline placebo will be infused intraoperatively.
Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.
Also known as: Versed
Sevoflurane for anesthesia induction.
Combination of NO2 \& O2 for anesthesia induction.
Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.
Morphine 0.1 mg/kg given prior to intubation.
Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.
Also known as: Zofran
Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis.
FLACC Pain Score Greater Than or Equal to 4
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score \>/= 4 at one or more time points.
Time frame: 0-60 mins post-operatively
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.
Time frame: 8-12 hours post-operatively
Time of First Opioid Analgesia in PACU
Mean time to first drug administration among patients requiring opioid analgesia in the PACU.
Time frame: 0-90 minutes post-operatively
| Milestone | IV Acetaminophen | Saline Placebo |
|---|---|---|
| Started | 125 | 125 |
| Completed | 118 | 121 |
| Not completed | 7 | 4 |
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score \>/= 4 at one or more time points.
| Participants | IV Acetaminophen | Saline Placebo |
|---|---|---|
| FLACC Pain Score Greater Than or Equal to 4 | 58 | 69 |
Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.
| Participants | IV Acetaminophen | Saline Placebo Infused Intraoperatively |
|---|---|---|
| hydrocodone/acetaminophen | 68 | 57 |
| oxycodone | 31 | 39 |
| NSAIDS | 15 | 22 |
| acetaminophen | 3 | 2 |
| morphine | 1 | 0 |
Mean time to first drug administration among patients requiring opioid analgesia in the PACU.
| minutes | IV Acetaminophen | Saline Placebo Infused Intraoperatively |
|---|---|---|
| Time of First Opioid Analgesia in PACU | 56.80 ± 14.15 | 60.46 ± 20.51 |
Collected over Adverse event data were collected for each patient from pre-operative registration, peri-operatively, until hospital discharge post-operatively (Data collection occurred over the course of a 24 hour period).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Acetaminophen | — | 0/118 (0%) | 11/118 (9.3%) |
| Saline Placebo | — | 0/121 (0%) | 16/121 (13.2%) |
| Event | IV Acetaminophen | Saline Placebo |
|---|---|---|
| Respiratory complicationsRespiratory, thoracic and mediastinal disorders | 10/118 | 12/121 |
| Post-operative nausea or vomiting (PONV)General disorders | 1/118 | 4/121 |
| Age, Continuous(years) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 4.87 ± 1.53 | 4.84 ± 1.42 | 4.855 ± 1.476 |
| Sex: Female, Male(Participants) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Female | 62 | 59 | 121 |
| Male | 56 | 62 | 118 |
| Height (cm)(centimeters) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 109.31 ± 10.82 | 108.78 ± 10.37 | 109.04 ± 10.58 |
| Weight (kg)(kilograms) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 18.85 ± 4.74 | 18.27 ± 4.02 | 18.56 ± 4.39 |
| Body Mass Index (kg/m2)(Kg/m2) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 15.56 ± 1.58 | 15.29 ± 1.36 | 15.42 ± 1.47 |
| Procedure time (min)(minutes) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 15.85 ± 5.78 | 16.65 ± 5.90 | 16.26 ± 5.85 |
| Extubation time (min)(minutes) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 16.65 ± 7.68 | 15.38 ± 8.52 | 16.01 ± 8.12 |
| Post-Anesthetic Care Unit time (min)(minutes) | IV Acetaminophen | Saline Placebo | Total |
|---|---|---|---|
| Mean | 64.57 ± 23.41 | 65.07 ± 19.40 | 64.82 ± 21.44 |
1 further baseline measures are reported on the registry.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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